A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA)
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Knee Osteoarthritis (OA)
In brief
This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.
Key facts
- Study ID
- NCT00536302
- Run by
- GELITA
- People needed
- 30
- Starts
- 2007-03-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2009-02-06
Who can join
Age: 49 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age > 49 years
- chronic knee discomfort based on the affirmative response to the question "During the past 6 months, have you had any pain in the knee more than half the days of the month ?"
- WOMAC pain subscale score ≥ 1
- tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
- clinical examination confirming knee pain or discomfort referable to the knee joint
- prepared to refrain from use of glucosamine, chondroitin, sAME and doxycycline
- stable medication and/or supplement use
You may not qualify if…
- use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
- serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
- individuals who are expected not to comply with the study protocol
- plan to permanently relocate from the region during the trial period
- planned knee arthroplasty in the study knee
- active pathology of confounding origin which may cause pain, extending to the knee
- pregnancy
- any contra-indication to having an MRI scan
Where it is running
- Tufts Medical Center; Center for Arthritis and Rheumatic Diseases — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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