NCT06693648

A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Once Daily Diclofenac Gel AMZ001 in the Treatment of Pain and Symptoms of Knee Osteoarthritis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Amzell · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 6-week trial of a formulation of AMZ001 once daily versus placebo once daily.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 6-week trial of a formulation of AMZ001 once daily versus placebo once daily. Participants will be evaluated for osteoarthritis by X-ray images of the knees and one knee will be selected for treatment as the target knee. The study gel will be applied directly to that knee throughout the 6 weeks of the study.

Conditions

• Osteoarthritis of Knee
• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	AMZ001 Diclofenac gel	Diclofenac gel applied once daily
DRUG	Placebo gel	Matching placebo gel applied once daily

Timeline

• Start date: 2025-02-18
• Primary completion: 2025-12-22
• Completion: 2026-04-01
• First posted: 2024-11-18
• Last updated: 2026-01-16

Locations

11 sites across 5 countries: United States, China, Czechia, Denmark, Poland

Regulatory

• FDA-regulated drug study