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AMZ001 diclofenac gel for Osteoarthritis (AMZ001 Trial)

Phase 3
Waitlist Available
Research Sponsored by Amzell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participant is able to read and understand the language and content of the study material, understand the requirements for study visits, and is willing to provide information at the scheduled evaluations and appropriate written informed consent has been obtained.
* Femorotibial osteoarthritis (OA) of the knee, according to the American College of Rheumatology (ACR) clinical and radiographic criteria (Altman et al. 1986)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.

Eligible Conditions
  • Osteoarthritis
  • Knee Arthritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AMZ001 diclofenac gelExperimental Treatment1 Intervention
Group II: Placebo gelPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

AmzellLead Sponsor
3 Previous Clinical Trials
518 Total Patients Enrolled
1 Trials studying Osteoarthritis
444 Patients Enrolled for Osteoarthritis
~360 spots leftby Nov 2025
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