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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05838742
Registration number
NCT05838742
Ethics application status
Date submitted
20/04/2023
Date registered
3/05/2023
Titles & IDs
Public title
A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain
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Scientific title
A Multicentre Randomized, Double-blind, Placebo Controlled, Dose-finding, Phase 2 Study (MARS-17) of GSK3858279 in Adult Participants With Moderate to Severe Pain Due to Knee Osteoarthritis
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Secondary ID [1]
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2022-502799-22-00
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Secondary ID [2]
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209978
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Universal Trial Number (UTN)
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Trial acronym
MARS-17
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain
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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 - GSK3858279
Treatment: Drugs - Placebo
Experimental: GSK3858279 Dose 1 - Participants will receive GSK3858279 dose 1.
Experimental: GSK3858279 Dose 2 - Participants will receive GSK3858279 dose 2.
Experimental: GSK3858279 Dose 3 - Participants will receive GSK3858279 dose 3.
Experimental: GSK3858279 Dose 4 - Participants will receive GSK3858279 dose 4.
Placebo comparator: Placebo - Participants will receive placebo.
Treatment: Drugs: GSK3858279
GSK3858279 will be administered.
Treatment: Drugs: Placebo
Placebo will be administered.
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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 Week 12 in weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS)
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Assessment method [1]
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To capture information on the self-reported average knee pain intensity in index knee, over the past 24 hours, participants will be asked to mark their average pain-intensity daily, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [1]
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Change from baseline at Week 12 in Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score
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Assessment method [1]
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The WOMAC proprietary set of standardized questionnaires used by health professionals and to evaluate the condition of participants with osteoarthritis of the knee and hip, including pain, stiffness of the joints. The questionnaire covers pain, stiffness and function related to OA in the index knee over the past 48 hours. Participants will respond to each question using an 11- point NRS (0-10), with 0 = no pain/stiffness/difficulty, and 10 = extreme pain/stiffness/difficulty.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Change from baseline at Week 12 in WOMAC function subscale score
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Assessment method [2]
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The WOMAC is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of participants with osteoarthritis of the knee and hip, for physical functioning of the joints. The questionnaire covers pain, stiffness and function related to OA in the index knee over the past 48 hours. Participants will respond to each question using an 11- point NRS (0-10), with 0 = no pain/stiffness/difficulty, and 10 = extreme pain/stiffness/difficulty.
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [3]
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Change from baseline at Week 12 in patient global assessment of disease (PtGA)
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Assessment method [3]
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The PtGA is assessment of study participant for disease conditions and intensity of knee OA pain. Participants will respond on a Likert scale ranging from 1-5. Higher scores indicate worse condition.
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Timepoint [3]
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Baseline and Week 12
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Secondary outcome [4]
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Occurrence of adverse events (AEs), serious AE (SAEs) and AEs of special interest (AESI)
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Assessment method [4]
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AEs, SAEs, and AESIs will be collected. Any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, tuberculosis (TB) and TB reactivation, serious hypersensitivity reactions and Injection site reactions.
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Timepoint [4]
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Up to 31 weeks
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Secondary outcome [5]
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Change from Baseline in Haematology Parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, white blood cell (WBC), and platelet count (Giga cells per liter)
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Assessment method [5]
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Timepoint [5]
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Baseline and up to Week 31
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Secondary outcome [6]
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Change from Baseline in Haematology Parameters: Red blood cell (RBC) count, (Trillion cells per liter)
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Assessment method [6]
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Timepoint [6]
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Baseline and up to Week 31
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Secondary outcome [7]
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Change from baseline in haematology parameter: Haemoglobin (Hb) (Grams per liter)
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Assessment method [7]
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Timepoint [7]
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Baseline and up to Week 31
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Secondary outcome [8]
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Change from baseline in haematology parameter: Haematocrit (Proportion of red blood cells in blood)
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Assessment method [8]
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Timepoint [8]
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Baseline and up to Week 31
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Secondary outcome [9]
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Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma-glutamyl transferase (GGT), and Alkaline Phosphatase (AP) (International units per liter)
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Assessment method [9]
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Timepoint [9]
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Baseline and up to Week 31
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Secondary outcome [10]
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Change from baseline in clinical chemistry parameter: Total bilirubin (Micromoles per liter)
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Assessment method [10]
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Timepoint [10]
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Baseline and up to Week 31
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Secondary outcome [11]
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Number of participants with greater than or equal to (=) grade 3 hematological/clinical chemistry abnormalities according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE)
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Assessment method [11]
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Hematological/clinical chemistry abnormalities summarized according to NCI CTCAE grade
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Timepoint [11]
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Up to 31 weeks
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Secondary outcome [12]
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Population parameters for the model describing the relationship between Dose, PK and response assessed on the NRS
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Assessment method [12]
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Longitudinal dose-exposure-response (D-E-R) relationship between GSK3858279 dose, PK and weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS). Where the pain is scored on a 11-point scale (0-10), with 0 = no pain, and 10 = extreme pain as bad as you can imagine.
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Timepoint [12]
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At Week 12
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Secondary outcome [13]
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Maximum observed concentration (Cmax) of GSK3858279
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Assessment method [13]
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Cmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
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Timepoint [13]
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At Week 12
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Secondary outcome [14]
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The amount of time for GSK3858279 to reach Cmax (tmax)
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Assessment method [14]
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Tmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
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Timepoint [14]
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At Week 12
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Secondary outcome [15]
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Pre-dose (trough) concentration at the end of the dosing interval (Ctau) of GSK3858279
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Assessment method [15]
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Ctau predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
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Timepoint [15]
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At Week 12
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Secondary outcome [16]
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Average concentration over a dosing interval (Cavg) of GSK3858279
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Assessment method [16]
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Cavg predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
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Timepoint [16]
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At Week 12
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Secondary outcome [17]
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Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279
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Assessment method [17]
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AUC(0-tau) predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
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Timepoint [17]
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At Week 12
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Eligibility
Key inclusion criteria
* Participant must be 40 to 80 years of age inclusive
* OA of the index knee as defined by symptomatic for = 6 months with a clinical diagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosis criteria.
* Kellgren and Lawrence (KL) score = 2 on X-ray in the index knee
* An average of the average daily pain score of =4 and less than or equal to (=) 9 by the 11-point NRS (0-10)
* Body mass index (BMI) of < 40 kilogram per meter square (kg/m^2) (inclusive).
* Capable of giving signed informed consent.
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Minimum age
40
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Maximum age
80
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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
* History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
* History or current evidence of any inflammatory arthritis such as rheumatoid arthritis, infective arthritis, Paget's disease, osteonecrosis, osteoporotic fracture, or any other joint disease that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of osteoarthritis.
* History of significant trauma or surgery to a knee or hip within the last 6 months.
* Current immunodeficiency diseases including but not limited to acquired immunodeficiency disorder or immunoglobulin deficiency.
* Current or previous active Mycobacterium tuberculosis
* History or evidence of clinically significant multiple or severe drug allergies
* History of malignancy within the last 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).
* Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35 percent (%)
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Evidence of renal insufficiency, indicated by estimated creatinine clearance < 60 millilitre/ minute (mL/min)/1.73 m^2 at screening.
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
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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 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
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
13/09/2023
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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
20/10/2025
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Actual
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Sample size
Target
420
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Botany
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Recruitment hospital [2]
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GSK Investigational Site - Campbelltown
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Recruitment hospital [3]
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GSK Investigational Site - Kotara
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Recruitment hospital [4]
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GSK Investigational Site - Camberwell
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Recruitment postcode(s) [1]
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2019 - Botany
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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Recruitment postcode(s) [3]
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2289 - Kotara
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Recruitment postcode(s) [4]
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3124 - Camberwell
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Recruitment outside Australia
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California
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Florida
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Kansas
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Louisiana
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New York
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North Carolina
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Argentina
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Buenos Aires
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Liaoning
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Tianjin
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Cahors
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Manchester
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Norwich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis (OA) pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.
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Trial website
https://clinicaltrials.gov/study/NCT05838742
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Phone
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Fax
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Email
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Contact person for public queries
Name
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US GSK Clinical Trials Call Center
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Address
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Phone
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877-379-3718
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
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Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05838742