Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients

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.

Timeline

Start

2019-03-29

Primary completion

2019-12-29

Completion

2019-12-29

Drugs

Indications