Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Phase 2 multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to
evaluate the efficacy, safety, and local tolerability of G001 topical gel compared to
matching Vehicle topical gel in patients with symptomatic OA of the knee.
Each patient's participation is approximately 7 weeks (~1 week screening, 4 weeks of
treatment, and 2 weeks of post-treatment follow-up). Eligible patients with adequate OA pain
in the index knee are randomized (1:1 allocation ratio) at the Baseline/Flare Visit 1.
Following screening, prior NSAID and/or acetaminophen use is discontinued to allow for
washout and symptom flare. Patients are instructed to rate their worst daily and nightly pain
in their daily diary, as well as to document all study drug applications and any rescue
medication (acetaminophen) use for breakthrough pain. Acetaminophen may be used as rescue
medication only, except within 12 hours prior to the Baseline Visit and within 12 hours prior
to any post-baseline efficacy assessments (Weeks 2, 4, and 5). Patients are instructed to
return to the clinic 3 to 7 days after the last study drug application for Flare Visit 2, and
within approximately 2 weeks after the last study drug application for end-of-study
evaluations.