CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 444 enrolled
Drug / intervention
AMZ001 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03691844
NCT03691844Phase 3Completed

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

Amzell·interventional·Posted Oct 2, 2018·Updated Oct 6, 2020

In Brief

A Phase 3 clinical trial evaluating AMZ001, Placebo, and 1 other intervention for Osteoarthritis, Knee. Completed, enrolled 444 participants across 7 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Denmark, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2, 2018
Enrollment StartOct 4, 2018
Primary CompletionJul 9, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.8 years ago

Interventions

AMZ001drug

diclofenac gel

Placebodrug

Placebo

Comparatordrug

diclofenac gel