NCT03691844

AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

A Placebo-controlled, Double-blind, Randomized, Trial of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 444 (actual)
• 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, 4-week trial of a formulation of AMZ001 once or twice daily versus placebo twice daily, including a single-blind treatment group with a commercial gel four times daily.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week trial of a formulation of AMZ001 once or twice daily versus placebo twice daily, including a single-blind treatment group with a commercial gel four times 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 4 weeks of the study.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	AMZ001	diclofenac gel
DRUG	Placebo	Placebo
DRUG	Comparator	diclofenac gel

Timeline

• Start date: 2018-10-04
• Primary completion: 2019-07-09
• Completion: 2019-07-09
• First posted: 2018-10-02
• Last updated: 2020-10-06
• Results posted: 2020-10-06

Locations

7 sites across 3 countries: United States, Czechia, Denmark

Regulatory

• FDA-regulated drug study