Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06693648 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
A Phase 3 study of Osteoarthritis, Knee and Osteoarthritis of Knee, sponsored by Amzell.
- Active
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
- 11
- Study locations
NCT06693648: Active Phase 3 study of Osteoarthritis, Knee and Osteoarthritis of Knee, sponsored by Amzell.
NCT06693648 is a Phase 3 study of Osteoarthritis, Knee and Osteoarthritis of Knee that is active but no longer recruiting, run by Amzell. The registered enrollment target is 540 participants, above the 493-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (10% higher). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06693648, a Phase 3 study of Osteoarthritis, Knee and Osteoarthritis of Knee, is active but no longer recruiting, sponsored by Amzell.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
Change from baseline in the WOMAC pain sub-score in the target knee at week 2. WOMAC: Western Ontario and McMasters University Osteoarthritis Index Participants will answer all of the 5 questions of WOMAC pain sub-score for themselves, using an 11-box numerical rating scale (with categories of 0 to 10), with reference to the past 24 hours. For convenience and ease of interpretation, total WOMAC pain sub-score will be normalized on scales of 0 to 100 points. Scale: 0-100, 100 being the worse
Conditions Studied
Interventions
- DRUG Placebo gel
- DRUG AMZ001 Diclofenac gel
Study Locations (11)
Other
- hong Kong Center for Clinical Research - Hong Kong
- Charles University - Prague
- Sanos Clinic - Herlev
- Medyczne Centrum Hetmanska Piotr Leszczynski - Poznan
Florida
- Eastern Research Inc - Hialeah
- Future Medical Research - Longwood
California
- Millennium Clinical Trials - Thousand Oaks
Louisiana
- DelRicht Research - New Orleans
Maryland
- DelRicht Research - Rockville
Michigan
- Oakland Medical Research - Troy
North Carolina
- West Clinical Research - Morehead City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2025-02-18 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
What the registry record for NCT06693648 still lists
NCT06693648 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, above the 493-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (10% higher).
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo gel is the first listed.
NCT06693648 lists 11 locations in 7 states (Other, Florida, California).
Frequently Asked Questions
What is clinical trial NCT06693648 about?
NCT06693648 is a clinical study titled "A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms". 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.
What is the current status of trial NCT06693648?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2025-02-18. Estimated completion is 2026-04.
What conditions does trial NCT06693648 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Osteoarthritis of Knee.
What interventions are being tested in trial NCT06693648?
The interventions under investigation include: Placebo gel (DRUG), AMZ001 Diclofenac gel (DRUG).
Who is sponsoring clinical trial NCT06693648?
This trial is sponsored by Amzell, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06693648 being conducted?
This trial has 11 study locations across California, Florida, Louisiana, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06693648's enrollment target sits among peer trials
540 18th of 112 higher than 95 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee 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
-
A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.
RECRUITING · Phase 3
-
Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans
RECRUITING · Phase 3
-
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
ACTIVE NOT RECRUITING · Phase 3
-
Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis
ACTIVE NOT RECRUITING · Phase 3
-
Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04557462 · 540 participants · Phase 3
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
- NCT04956640 · 540 participants · Phase 1
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
- NCT05429892 · 540 participants · NA
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers
- NCT05549297 · 540 participants · Phase 3
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI