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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04809376
Registration number
NCT04809376
Ethics application status
Date submitted
18/03/2021
Date registered
22/03/2021
Date last updated
8/04/2024
Titles & IDs
Public title
Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain
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Scientific title
A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared With Placebo in Participants With Knee Osteoarthritis Pain
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Secondary ID [1]
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PARA_OA_002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pentosan Polysulfate Sodium twice weekly
Treatment: Drugs - Placebo (Sodium Chloride Injection, 0.9%)
Treatment: Drugs - Pentosan Polysulfate Sodium Fixed Dose
Treatment: Drugs - Pentosan Polysulfate Sodium once weekly
Experimental: PPS Twice Weekly - Pentosan Polysulfate Sodium (PPS) twice weekly for 6 weeks
Experimental: PPS Once Weekly - Pentosan Polysulfate Sodium (PPS) + placebo once weekly for 6 weeks
Experimental: PPS Fixed Dose Once Weekly - Pentosan Polysulfate Sodium (PPS) Fixed dose (100mg,150mg, or 180mg) once weekly + placebo once weekly for 6 weeks
Placebo Comparator: Placebo - Placebo twice weekly for 6 weeks
Treatment: Drugs: Pentosan Polysulfate Sodium twice weekly
Subcutaneous Injection, 1.5mg/kg Ideal body Weight (IBW)
Treatment: Drugs: Placebo (Sodium Chloride Injection, 0.9%)
Placebo to match PPS
Treatment: Drugs: Pentosan Polysulfate Sodium Fixed Dose
Subcutaneous Injection, 100/150/180 mg if <65kg/ = 65 kg and = 90kg/ >90 kg IBW
Treatment: Drugs: Pentosan Polysulfate Sodium once weekly
Subcutaneous Injection, 2.0mg/kg Ideal body Weight (IBW)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline at Day 56 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index.
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Assessment method [1]
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WOMAC: The WOMAC® NRS 3.1 Index is a validated, self-administered, health status questionnaire that assesses pain, stiffness, and function in patients with hip or knee OA . The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours. It is calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain sub-scale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
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Timepoint [1]
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Baseline, Day 56
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Secondary outcome [1]
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Key secondary: Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index
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Assessment method [1]
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WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
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Timepoint [1]
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Baseline to Day 56
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Secondary outcome [2]
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Key secondary: Change from baseline at Day 84 in knee pain as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index
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Assessment method [2]
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WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
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Timepoint [2]
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Baseline to Day 84
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Secondary outcome [3]
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Key secondary: Change from baseline at Day 84 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index
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Assessment method [3]
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WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
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Timepoint [3]
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Baseline to Day 84
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Secondary outcome [4]
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Stage 1 only: Change from baseline at Day 56 and 84 in knee pain as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index for PPS 1.5 mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly
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Assessment method [4]
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WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
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Timepoint [4]
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Baseline to Day 56 and Day 84
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Secondary outcome [5]
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Stage 1 only: Reduction in knee pain of = 30% and = 50% as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly
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Assessment method [5]
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WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
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Timepoint [5]
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Baseline to Day 56 and Day 84
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Secondary outcome [6]
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Stage 1 only: Stage 1 only: Change from baseline at Day 56 and 84 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index for PPS 1.5 mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly
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Assessment method [6]
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WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
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Timepoint [6]
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Baseline to Day 56 and Day 84
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Secondary outcome [7]
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Stage 1 only: Improvement in function of = 30% and = 50% as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly
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Assessment method [7]
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WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
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Timepoint [7]
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Baseline to Day 56 and Day 84
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Secondary outcome [8]
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Stage 1 only: PGIC scores at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly
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Assessment method [8]
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The PGIC is a self-administered question that rates participants overall improvement in chronic pain since beginning treatment from 1 "no change (or condition has worsened)" to 7 "a great deal better" in response to the question "Since beginning treatment, how would you describe the change (if any) in activity, limitation, symptoms, emotions, and overall QoL related to your arthritis".
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Timepoint [8]
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Baseline to Day 56 and Day 84
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Secondary outcome [9]
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Stage 1 and 2: Outcomes Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index response rate at Days 39, 56, 84, 112, 140, and 168
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Assessment method [9]
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Participants are considered as an OMERACT-OARSI responder: if the change (improvement) from baseline to day of interest was greater than or equal to >= 50 percent and >= 2 units in either WOMAC pain sub-scale or physical function sub-scale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain sub-scale score, 2) WOMAC physical function sub-scale score, 3) Patient Global Impression of Change (PGIC).
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Timepoint [9]
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Baseline, Days 39, 56, 84, 112, 140 and 168
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Secondary outcome [10]
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Stage 1 and 2: Change from baseline at Days 11, 25, 39, 112, 140 and 168 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index.
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Assessment method [10]
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WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
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Timepoint [10]
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Baseline, Days 11, 25, 39, 112, 140 and 168
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Secondary outcome [11]
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Stage 1 and 2: Change from baseline in knee pain of >=30% and >=50% as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 112, 140, and 168
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Assessment method [11]
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Percentage of participants with reduction in WOMAC pain intensity of at least >=30% or >=50% compared to baseline as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168.
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Timepoint [11]
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Baseline, Days 11, 25, 39, 112, 140 and 168
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Secondary outcome [12]
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Stage 1 and 2: Change from baseline at Days 11, 25, 39, 112, 140 and 168 in function as assessed by the average functional sub-scale score of the WOMAC® Index.
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Assessment method [12]
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WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
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Timepoint [12]
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Baseline, Days 11, 25, 39, 112, 140 and 168
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Secondary outcome [13]
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Stage 1 and 2: Improvement in function of >=30% and >=50% as assessed by the average functional sub-scale score of the WOMAC® NRS 3.1 Index from baseline at Days 11, 25, 39, 112, 140, and 168
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Assessment method [13]
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Percentage of participants with improvement in WOMAC function of at least >=30% or >=50% compared to baseline as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168.
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Timepoint [13]
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Baseline, Days 11, 25, 39, 112, 140, and 168
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Secondary outcome [14]
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Stage 1 and 2: Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 in knee stiffness as assessed by the average stiffness sub-scale score of the WOMAC® NRS 3.1 Index
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Assessment method [14]
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WOMAC: The WOMAC stiffness sub-scale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee) during the past 48 hours.
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Timepoint [14]
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Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168
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Secondary outcome [15]
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Stage 1 and 2: Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 overall as assessed by the overall score of WOMAC® NRS 3.1 Index
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Assessment method [15]
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WOMAC: The WOMAC® NRS 3.1 Index consists of 24 questions and produces 3 sub-scales scores for pain (5 questions), stiffness (2 questions), and function (17 questions) and a total score that summarizes overall disability.
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Timepoint [15]
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Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168
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Secondary outcome [16]
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Stage 1 and 2: Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
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Assessment method [16]
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The SF-36 v2 is a 36-item, patient-reported survey of patient health, consisting of 8 scaled scores, which are the weighted sums of the questions in their section. The 1-week recall form asks the respondent to answer the questions as they pertain to the way he or she felt or acted during the past week.
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Timepoint [16]
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Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168
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Secondary outcome [17]
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Stage 1 and 2: PGIC scores at Days 39, 112, 140, and 168
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Assessment method [17]
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The PGIC is a self-administered question that rates participants overall improvement in chronic pain since beginning treatment from 1 "no change (or condition has worsened)" to 7 "a great deal better" in response to the question "Since beginning treatment, how would you describe the change (if any) in activity, limitation, symptoms, emotions, and overall QoL related to your arthritis".
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Timepoint [17]
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Baseline, Days 39, 112, 140, and 168
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Secondary outcome [18]
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Stage 1 and 2: Change from baseline at Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score
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Assessment method [18]
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This WPAI questionnaire (WPAI:OA-knee) is a validated self-administered questionnaire that assesses work impairment due to OA . The questionnaire gathers information on employment status, hours worked, hours missed due to OA, and hours missed for any other reasons.
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Timepoint [18]
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Baseline, Day 56, 84, 112, 140 and 168
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Secondary outcome [19]
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Stage 1 and 2: Number of days of rescue medication used from Day 1 to Day 168
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Assessment method [19]
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In case of inadequate pain relief, either acetaminophen/paracetamol up to 3000 mg per day or topical analgesics, up to 4 days in a week could be taken as rescue medication between day 1 and Day 168. Number of participants with any use of rescue medication during the particular study week will be summarized
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Timepoint [19]
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Baseline up to Day 168
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Secondary outcome [20]
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Stage 1 and 2: Incidence of treatment-emergent Adverse Event (TEAEs), including serious AEs (SAEs)
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Assessment method [20]
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
An SAE is any untoward medical occurrence that at any dose results in one or more of the following outcomes: death; life-threatening; requires in-patient hospitalization or prolongation of an existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; is an important medical event. Treatment-emergent are events between the first dose of study drug and up to Day 168 that were absent before treatment or that worsened relative to pre-treatment state.
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Timepoint [20]
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Baseline up to Day 168
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Secondary outcome [21]
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Stage 1 and 2: Treatment-emergent clinical laboratory abnormalities
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Assessment method [21]
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Treatment-emergent clinical laboratory abnormalities are abnormalities in labs between the first dose of study drug and up to Day 168 that were absent before treatment or that worsened relative to pre-treatment state
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Timepoint [21]
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Baseline up to Day 168
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Secondary outcome [22]
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Stage 1 and 2: Clinically significant changes in electrocardiograms (ECG) compared with baseline (pharmacokinetic [PK] subset only)
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Assessment method [22]
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Clinically significant changes in ECGs between the first administration of study drug and up to Day 39 that were absent before treatment or that worsened relative to pre-treatment state.
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Timepoint [22]
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Baseline, Day 1, Day 15, Day 36 and Day 39
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Eligibility
Key inclusion criteria
- Participant must be >= 18 years of age inclusive, at the time of signing the informed
consent.
- Clinical diagnosis of OA in the index knee by American College of Rheumatology
criteria 1986 criteria.
- Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L Grade 2,
3, or 4 on standing anterior-posterior X-ray of the index knee.
- Osteoarthritis pain in the index knee unresponsive (ie, the participant still
experiences pain) to conservative therapy for = 6 months preceding Screening, defined
as history indicating that:
1. Acetaminophen/paracetamol therapy has not provided sufficient pain relief or
participant is unable to take acetaminophen/paracetamol chronically/long term
because of contraindication or inability to tolerate; AND
2. At least 1 oral non-steroidal anti-inflammatory drug (NSAID, including
cyclooxygenase-2 inhibitors) and/or topical NSAID therapy that has not provided
sufficient pain relief or participant is unable to take NSAIDs because of
contraindication or inability to tolerate.
- Average WOMAC NRS 3.1 Index pain sub-scale score of 4 to 10 in the index knee at
Screening AND a minimum pain score of 4 on either of the individual WOMAC NRS 3.1
Index questions of pain on walking on a flat surface or pain on climbing stairs at
Screening.
- Average WOMAC NRS 3.1 Index function sub-scale score of 4 to 10 in the index knee at
Screening.
- Body mass index of >=18 to <=39.0 kg/m2
- Female subjects of childbearing potential and Male subjects must agree to comply with
protocol specified contraceptive requirements
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.
- Current non-pharmacologic treatment regimen for knee OA (excluding knee brace) must be
stable for at least 2 weeks before Day 1 and remain stable throughout the study.
Participant must be willing to abstain from starting a new or changing their
non-pharmacologic treatment regimen for the duration of the study.
- Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain
medications (except acetaminophen/paracetamol per rescue protocol) from 2 weeks before
Day 1 to end of study.
- Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are
prohibited) as rescue therapy if required.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Documented or reported history of increased bleeding in the absence of anticoagulant
or antiplatelet drugs or prior history of major bleeding episode in the presence of
anticoagulant or antiplatelet therapy.
- History of idiopathic or immune-mediated thrombocytopenia including history of or
laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4
[ie, PF4] and positive Serotonin Release Assay (SRA)].
- Currently active or recent history (within preceding 12 months) of a gastric or
duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
- History of other bleeding disorders including haemophilia
•. Recent cerebral bleeding or operation on brain, spine, or eyes within 6 months of
Day 1.
- Spinal anaesthesia within 14 days of Day 1,
- Fibromyalgia, regional pain caused by lumbar or cervical compression with
radiculopathy, or other moderate to severe pain that may confound assessments or
self-evaluation of the pain associated with osteoarthritis. Participants with a
present (current) history of sciatica are not eligible for participation. Participants
with a history of sciatica who have been asymptomatic for = 3 months and who have no
evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are
eligible for participation.
- History of other disease that may involve the index joint, including inflammatory
joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg,
ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related
arthropathy), crystalline disease (eg, gout), endocrinopathies, metabolic joint
diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
- History of osteonecrosis or osteoporotic fracture (ie, a participant with a history of
osteoporosis and a minimally traumatic or atraumatic fracture).
- History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a
similar chemical or pharmacological class.
- Predisposition to hypersensitivity due to multiple (2 or more) atopic diseases (such
as atopic eczema, asthma, and chronic allergic rhinitis and/or rhinoconjunctivitis) or
multiple (2 or more) severe allergies
- Allergy or contraindication to Tetracosactide
- Chronic medical conditions including but not limited to those stated below requiring
medical regime changes within 60 days before Day 1. Concurrent unstable peripheral,
cardiac, and cerebral vascular disease, poorly controlled chronic obstructive
pulmonary disease and asthma, coagulopathies, uncontrolled neurological conditions,
active tuberculosis, active infections, symptomatic cardiac arrhythmias, adrenal
insufficiency (primary or central), nephrotic syndrome, Cirrhosis (Child-Pugh stage B
or C), uncontrolled diabetes and uncontrolled hypothyroidism or hyperthyroidism, or
mental or emotional disorders that preclude reliable study participation.
- History of pituitary irradiation or recent (within 1 year) history of transsphenoidal
surgery
- Any cancer within the previous 5 years, except for basal cell carcinomas.
- Current hyperkalemia and/or hyponatremia.
- History or current autoimmune polyglandular syndromes
- Presence of any underlying physical or psychological medical condition that, in the
opinion of the Investigator, would make it unlikely that the participant will comply
with the protocol or complete the study per protocol.
- Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin =100
mg/day.
- Previous treatment with PPS in any form.
- Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory
(with immunosuppressive effects) systemic therapy including but not limited to oral,
inhaled, intranasal, intra-articular and topical corticosteroids (occasional use of
topical, inhaled or intranasal corticosteroids is acceptable).
- Use of opioids within 6 weeks before Day 1.
- Use of bisphosphonates within 12 weeks before Day 1.
- Use of denosumab and iloprost within 12 weeks before Day 1.
- Use of a knee brace on the index knee within 2 weeks before Day 1.
- Systemic steroids administered intravenously, intramuscularly, and orally for OA or
other indications within 8 weeks before Day 1.
- Intra-articular injections to the index knee: steroids within 24 weeks; hyaluronic
acid or any other intra-articular injections within 24 weeks before Day 1.
- Cannabinoids within 30 days before Day 1.
- Use of vitamins and dietary supplements known to alter haemostasis within 2 weeks
before Day 1, including ajoene, birch bark, cayenne, Chinese black tree fungus, cumin,
evening primrose oil, feverfew, garlic, ginger, ginkgo biloba, ginseng, grapeseed
extract, milk thistle, omega 3 fatty acids, onion extract, St. John's wort, turmeric,
vitamins C and E, vitamin K.
- Known exposure to heparin within the last 100 days as determined by history of drug
use or history of the following medical conditions or interventions: cardiac bypass
surgery or thromboembolic disease
- Treatment with dehydroepiandrosterone sulfates within 6 weeks before Day 1.
- Chronic use of oral glucocorticoid receptor antagonists or cortisol synthesis
inhibitors within12 weeks before Day 1.
- Biotin within 72 hours of screening.
- Megestrol Acetate within 6 weeks before Day 1
- Current treatment with any medication that may lead to Maculopathy (see Table 3)
- Any medication that alters sodium and/or potassium levels (see Table Prohibited
Therapy)
- Participation in another clinical trial or administration of any IP or experimental
product within 24 weeks or 5 half-lives (whichever is longer) before Day 1.
- Activated partial thromboplastin time [aPTT]) > 36 seconds, platelets <150,000/µL, or
liver enzyme tests (aspartate aminotransferase [AST] or alanine aminotransferase
[ALT]) = 2 × ULN at Screening.
- Active or chronic hepatitis B virus, hepatitis C virus, or uncontrolled HIV infection
(detectable virus or diagnosis of AIDS); participants with HIV infection must be on
chronic suppressive antiviral medication.
- Radiographic evidence of any of the following conditions in any Screening radiograph:
excessive malalignment of the knee, severe chondrocalcinosis; other arthropathies (eg,
rheumatoid arthritis, psoriatic arthritis, gout), systemic metabolic bone disease (eg,
Paget's disease, metastatic calcifications), primary or metastatic tumour lesions,
stress, or traumatic fracture.
- Radiographic evidence of any of the following conditions at Screening:
1. subchondral insufficiency fractures
2. spontaneous osteonecrosis of the knee
3. osteonecrosis
4. pathologic fracture
- Any clinically significant abnormalities on clinical chemistry, haematology,
urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as
judged by the Investigator (at Screening).
- Resting, supine blood pressure (BP) =160 mmHg in systolic pressure or =100 mmHg in
diastolic pressure at Screening. If a participant is found to have uncontrolled and/or
untreated significant hypertension at Screening and anti-hypertensive treatment is
initiated, assessment for study eligibility should be deferred until BP and
antihypertensive medication have been stable for at least 1 month. For participants
with previously diagnosed hypertension, antihypertensive medications must be stable
for at least 1 month before Screening.
- Evidence of pigmentary maculopathy identified by a retinal specialist during
Screening.
- Morning Cortisol = 3 µg/dL.
- ACTH <10 pg/ml; Morning Cortisol >3 µg/dL and <10 µg/dL and peak cortisol (by ACTH
stimulation test) <18 µg/dL.
- Largely or wholly incapacitated (eg, bedridden or confined to a wheelchair, permitting
little or no self-care).
- Major surgery or anticipated surgery during the study.
- Currently hospitalized or any planned hospitalizations during the study.
- Plan for total knee reconstruction in affected knee(s) during the study.
- Knee surgery or trauma to the index knee within 1 year before Day 1.
- A history of drug or alcohol abuse and/or dependence within the 12 months before
Screening that, in the opinion of the investigator, may affect participant ability to
comply with study requirements.
- An employee of the Sponsor, clinical research organisations or research site personnel
directly affiliated with this study or their immediate family members defined as a
spouse, parent, sibling, or child, whether biological or legally adopted.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
602
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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0
Australian Clinical Research Network - Maroubra
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Recruitment hospital [2]
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Griffith University - Southport
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Recruitment hospital [3]
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Sportsmed - Stepney
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Linear Clinical Research Limited - Nedlands
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2035 - Maroubra
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4222 - Southport
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5069 - Stepney
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Illinois
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Kansas
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Louisiana
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Nevada
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South Carolina
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Tennessee
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Paradigm Biopharmaceuticals USA (INC)
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Ethics approval
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Summary
Brief summary
The purpose of this study is to measure the change in pain and function with subcutaneous
injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of
placebo in participants with knee osteoarthritis pain.
Study details include:
- The study duration will be up to 31 weeks per participant
- The treatment duration will be 6 weeks.
- The visit frequency will be twice weekly during treatment.
- The visit frequency will be every 4 weeks during the follow-up period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04809376
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Public notes
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Contacts
Principal investigator
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Thomas Schnitzer
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Northwestern University Feinberg School of Medicine
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04809376
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