Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee

NCT05007808 PHASE2 COMPLETED Results posted

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.

Details

Lead sponsor	BUZZZ Pharmaceuticals Limited
Phase	PHASE2
Status	COMPLETED
Enrolment	210
Start date	Wed Jan 06 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Jan 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Osteoarthritis, Knee

Interventions

• G001 Topical Gel
• Vehicle

Countries

Canada