TreatMent Of Knee osTeoarthritis wIth chONdroitin Sulfate - the OA MOTION Study
brief summary
The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks). The primary outcome of interest will be the effect of chondroitin sulfate on pain in the index knee at week 24 compared to placebo. The effect of chondroitin sulfate in the index knee functionality and the patient global impression of changes at 24 weeks compared to placebo are included as key-secondary endpoints. An additional key secondary endpoint will assess the durability of the effect on pain compared to placebo at week 36. Several additional secondary endpoints are included to further support the beneficial effect of the treatment and the improvements in patient's quality of life (i.e., Western Ontario and McMaster Universities Arthritis Index -WOMAC- subscales and total scores at each study visits, changes in patient's quality of life, use of rescue medication etc.) other than the safety of the product.
detailed description
The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks). Approximately 690 male and female adult subjects with moderate-to-severe pain due to OA of the knee will be randomized in a 1:1 ratio to receive either chondroitin sulfate 800 mg tablets (CS) or matching placebo. Subjects will orally self administer chondroitin sulfate/placebo once daily at home during the double blind treatment period of 36 weeks. The first approximately 250 subjects who reach Week 36 and are willing to further participate in the study will attend a double blind long-term safety follow-up period and will continue to self administer chondroitin sulfate/placebo for 12 additional weeks (up to week48). Acetaminophen 500 mg oral tablets, max. 6 tablets per day (rescue medication), will be the only analgesic allowed for the clinical study to treat pain of any type.
The study will include the following endpoints:
Primary Efficacy (Double-blind Treatment Period until Week 36) • Change from Baseline to Week 24 in the weekly mean of the average daily pain in the index knee as measured by the numerical rating scale (NRS) (0 10 points)
Key Secondary Efficacy (Double-blind Treatment Period until Week 36)
* Change from Baseline to Week 24 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale * Subject's global evaluation at Week 24 as measured by Patient Global Impression of Change (PGIC) * Change from Baseline to Week 36 in the weekly mean of the average daily pain in the index knee as measured with the NRS (durability of effect)
Other Secondary Efficacy (Double-blind Treatment Period until Week 36)
* Change from Baseline to each week until Week 36 in the weekly mean of the average daily pain in the index knee as measured with the NRS * Change from Baseline to Weeks 4, 12, 24, and 36 in WOMAC total score and all WOMAC subscores * Consumption of rescue medication (acetaminophen), including the number of intake days, number of daily intakes, and total dose per day * Change from Baseline to Weeks 4, 12, 24, and 36 in subject's quality of life (Short Form 36 Health Survey Questionnaire \[SF-36\]) * Subject's global evaluation at Weeks 4, 12, and 36 as measured by PGIC * Investigator's global evaluation at Weeks 4, 12, 24, and 36 by Clinician Global Impression of Change (CGIC) * Responder rates at each visit using 2 different response definitions (≥30% or ≥50% decrease in weekly mean of the average daily \[24 hour\] NRS pain intensity score)
official title
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Chondroitin Sulfate 800 mg Tablets Versus Placebo in Subjects With Pain Due to Knee Osteoarthritis and to Evaluate the Durability of the Effect and Safety of the Treatment