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NCT03691844 · ClinicalTrials.gov registry record · Phase 2
AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
A Phase 2 study, sponsored by Amzell.
- Completed
- Registry status
- Phase 2
- Development phase
- 444
- Enrollment target
NCT03691844: Completed Phase 2 study, sponsored by Amzell.
NCT03691844 is a Phase 2 study that has completed, run by Amzell. The registered enrollment target is 444 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (234% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03691844, a Phase 2 study, has completed, sponsored by Amzell.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 444 participants
- Enrollment target
Study 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.
Primary Outcome
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain sub-score (questions 1-5; score 0 \[no pain\]-50 \[extreme pain\]) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Interventions
- DRUG Placebo
- DRUG Comparator
- DRUG AMZ001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2019-07-09 |
| Phase | Phase 2 |
What the finished NCT03691844 record still lists
NCT03691844 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (234% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03691844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03691844 about?
NCT03691844 is a clinical study titled "AMZ001 for the Treatment of Knee Osteoarthritis Symptoms". 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.
What is the current status of trial NCT03691844?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 444 participants. The study started on 2018-10-04. Estimated completion is 2019-07-09.
What interventions are being tested in trial NCT03691844?
The interventions under investigation include: Placebo (DRUG), Comparator (DRUG), AMZ001 (DRUG).
Who is sponsoring clinical trial NCT03691844?
This trial is sponsored by Amzell, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03691844's enrollment target sits among peer trials
444 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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