Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients
Status:
Unknown status
Trial end date:
2019-12-29
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of
ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis
knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to
each patient's pretreatment baseline WOMAC assessment.Safety will be assessed via
measurements of vital signs and clinical laboratory tests at baseline and at various time
points during the study, patient monitoring, and by the documentation of adverse events.