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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04123561
Registration number
NCT04123561
Ethics application status
Date submitted
9/10/2019
Date registered
11/10/2019
Titles & IDs
Public title
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee
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Secondary ID [1]
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TLC599A3005
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Universal Trial Number (UTN)
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Trial acronym
EXCELLENCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the 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 - TLC599
Treatment: Drugs - DSP
Other interventions - Normal Saline
Experimental: TLC599 - TLC599 (1mL) IA injection
Active comparator: Dexamethasone sodium phosphate - DSP 4mg (1mL) IA injection
Placebo comparator: Normal Saline - Normal saline (1mL) IA injection
Treatment: Drugs: TLC599
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
Treatment: Drugs: DSP
Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
Other interventions: Normal Saline
0.9% normal saline
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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 in WOMAC Pain
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Assessment method [1]
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Change from Baseline in WOMAC Pain
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Timepoint [1]
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Baseline, Week 12
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Secondary outcome [1]
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Change from Baseline in WOMAC Pain
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Assessment method [1]
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Change from Baseline in WOMAC Pain
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Timepoint [1]
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Baseline, Week 16
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Secondary outcome [2]
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Change from Baseline in WOMAC Pain
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Assessment method [2]
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Change from Baseline in WOMAC Pain
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Timepoint [2]
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Baseline, Week 20
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Secondary outcome [3]
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Change from Baseline in WOMAC Pain
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Assessment method [3]
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Change from Baseline in WOMAC Pain
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Change from Baseline in WOMAC Pain
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Assessment method [4]
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Change from Baseline in WOMAC Pain
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Timepoint [4]
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Baseline, Week 36
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Secondary outcome [5]
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Change from Baseline in WOMAC Function at Week 12 (Group A vs. Group C)
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Assessment method [5]
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Change from Baseline in WOMAC Function at Week 12 (Group A vs. Group C)
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Timepoint [5]
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Baseline, Week 12
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Secondary outcome [6]
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PGIC
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Assessment method [6]
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Patient Global Impression of Change
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Total rescue acetaminophen consumption
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Assessment method [7]
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Total rescue acetaminophen consumption
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Timepoint [7]
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through Week 12
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Secondary outcome [8]
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Durable responder with =30% decrease in WOMAC Pain from Baseline
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Assessment method [8]
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Durable responder with =30% decrease in WOMAC Pain from Baseline
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Timepoint [8]
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Weeks 4 through 12
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Secondary outcome [9]
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Change from Baseline in WOMAC Function
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Assessment method [9]
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Change from Baseline in WOMAC Function
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Timepoint [9]
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Baseline, Week 36
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Secondary outcome [10]
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PGIC
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Assessment method [10]
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Patient Global Impression of Change
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Timepoint [10]
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Week 36
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Secondary outcome [11]
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Change from Baseline in WOMAC Pain at Week 12 (Group A vs. Group B)
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Assessment method [11]
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Change from Baseline in WOMAC Pain at Week 12 (Group A vs. Group B)
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Timepoint [11]
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Baseline, Week 12
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Secondary outcome [12]
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Change from Baseline in WOMAC Pain at Week 52 (Group A vs. Group C)
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Assessment method [12]
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Change from Baseline in WOMAC Pain at Week 52 (Group A vs. Group C)
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Timepoint [12]
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Baseline, Week 52
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Eligibility
Key inclusion criteria
Male or female =40 years of age. BMI = 40 kg/m2. Radiographically documented OA with Kellgren-Lawrence severity Grade 2 or 3 and associated symptoms Patient-reported pain with NRS score =4 (on a 0-10 scale) Able to read, understand, and sign the informed consent form, communicate with the investigator, complete study diaries, and understand and comply with protocol requirements.
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Minimum age
40
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
Recent use of IA or systemic corticosteroids Patient who is not ambulatory Any surgery or arthroscopy in the index knee within 12 months Any condition that could possibly confound the patient's assessment of index knee pain Substance abuse disorder, or positive urine drug test for illegal drug substances History of acquired or congenital immunodeficiency diseases History of treated malignancy which is disease free for =5 years Known allergy or hypersensitivity to the study drugs or their components
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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 administering 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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
26/11/2019
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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
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Actual
3/02/2022
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Sample size
Target
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Accrual to date
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Final
506
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Genesis Research Services - Broadmeadow
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Recruitment hospital [2]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [3]
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Northern Sydney Local Health District - Saint Leonards
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Recruitment hospital [4]
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Austrials - Taringa
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Recruitment hospital [5]
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Colin Bayliss Research and Teaching Unit - Victoria Park
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Recruitment postcode(s) [1]
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2292 - Broadmeadow
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Recruitment postcode(s) [2]
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2035 - Maroubra
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Recruitment postcode(s) [3]
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2065 - Saint Leonards
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Recruitment postcode(s) [4]
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4068 - Taringa
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Recruitment postcode(s) [5]
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6100 - Victoria Park
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Recruitment outside Australia
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United States of America
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Alabama
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Connecticut
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Florida
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Illinois
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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Taiwan Liposome Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
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Trial website
https://clinicaltrials.gov/study/NCT04123561
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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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Carl Brown, PhD
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Address
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Taiwan Liposome Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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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)?
No
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No/undecided IPD sharing reason/comment
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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/NCT04123561