4 completed, 1 withdrawn. 3 Phase 3, 2 Phase 1, 1 Phase 2.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms AMZ001 Diclofenac gel, Placebo gel - Osteoarthritis of Knee, Osteoarthritis, Knee | Phase 3 | Completed | Amzell | 549 | 2025-02-18 | 2026-07-15 |
Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After Repeated Topical Administrations for 7 Days. Diclofenac sodium gel, Diclofenac diethylamine 1.16% gel - Healthy Volunteer | Phase 1 | Completed | Amzell | 34 | 2024-11-29 | 2026-01-06 |
Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants Diclofenac Sodium Gel - Healthy | Phase 1 | Completed | Amzell | 74 | 2023-07-11 | 2025-04-09 |
A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms AMZ002 injectable solution, 0.5mg/mL, Vigabatrin, oral - Spasms, Infantile | Phase 3 | Withdrawn | Amzell | | 2023-04-01 | 2023-04-20 |
AMZ001 for the Treatment of Knee Osteoarthritis Symptoms AMZ001, Placebo, Comparator - Osteoarthritis, Knee | Phase 2 / Phase 3 | Completed | Amzell | 444 | 2018-10-04 | 2020-10-06 |
Conditions studied
Osteoarthritis, Knee (2) · Central Nervous System Diseases (1) · Epileptic Syndromes (1) · Osteoarthritis (1) · Seizures (1) · Spasms, Infantile (1)
Interventions
Gels (1) · Vigabatrin (1) · diclofenac diethylamine (1)
Countries
United States (4) · Czechia (2) · Denmark (2) · Poland (2) · Argentina (1) · China (1) · France (1) · Germany (1) · India (1) · Italy (1) · Mexico (1) · Spain (1)