TreatMent Of Knee osTeoarthritis wIth chONdroitin Sulfate - the OA MOTION Study
Status:
Not yet recruiting
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
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.