diclofenac gel (AMZ001) / Amzell - LARVOL DELTA

Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants (clinicaltrials.gov) - P1 | N=74 | Completed | Sponsor: Amzell | Active, not recruiting ➔ Completed

Trial completion

AMZ001-007: A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Amzell | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

The Goal of This Clinical Trial is to Compare Drug Exposure from Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants on Day 7 After Repeated Topical Administrations for 7 Days. (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: Amzell

New P1 trial

AMZ001-007: A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms (clinicaltrials.gov) - P3 | N=540 | Not yet recruiting | Sponsor: Amzell

New P3 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants (clinicaltrials.gov) - P1 | N=74 | Active, not recruiting | Sponsor: Amzell | Trial completion date: May 2024 ➔ Sep 2024

Trial completion date

Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants (clinicaltrials.gov) - P1 | N=74 | Active, not recruiting | Sponsor: Amzell | Recruiting ➔ Active, not recruiting

Enrollment closed

Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: Amzell

New P1 trial

A novel diclofenac gel (AMZ001) applied once or twice daily in subjects with painful knee osteoarthritis: A randomized, placebo-controlled clinical trial. (PubMed, Semin Arthritis Rheum) - "Treatment with AMZ001 BID for 4 weeks improved WOMAC pain sub-scores; however, only QD application conferred nominally statistically significant improvements vs placebo. AMZ001 was generally well tolerated."

Clinical • Journal • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Phase 2/3 trial suggests that AMZELL’s new topical treatment (AMZ001) for the treatment of knee osteoarthritis symptoms is effective (PRWeb) - P2/3, N=444; NCT03691844; Sponsor: Amzell; "This phase 2/3 multi-center, randomized, double-blind trial investigated the effect of a new 3.06% diclofenac sodium gel formulation (AMZ001) for the relief of knee OA pain, in 444 patients exposed to either AMZ001 once daily (QD), AMZ001 twice daily (BID) or placebo. The trial also included an exploratory comparator treatment arm, Voltaren® Gel 1 % four times daily (QID)....For the primary analysis of change from baseline to week 4 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain sub-score, AMZ001 QD showed a nominally significant improvement in reducing the pain compared to placebo (p<0.05)."

P2/3 data • Osteoarthritis • Pain

[VIRTUAL] A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, TRIAL OF AMZ001 – A NOVEL DICLOFENAC SODIUM 3.06% GEL - FOR THE TREATMENT OF KNEE OSTEOARTHRITIS SYMPTOMS (EULAR 2020) - "AMZ001, a novel topical diclofenac formulation, either once or twice daily was efficacious in the treatment of knee OA pain with a good tolerability and safety profile, suggesting AMZ001 may be a promising alternative to existing pain-relieving treatments in knee OA."

Clinical • Dermatology • Dermatopathology • Immunology • Osteoarthritis • Pain • Rheumatology

AMZ001 for the Treatment of Knee Osteoarthritis Symptoms (clinicaltrials.gov) - P2/3; N=444; Completed; Sponsor: Amzell; Active, not recruiting ➔ Completed

Clinical • Trial completion

AMZ001 for the Treatment of Knee Osteoarthritis Symptoms (clinicaltrials.gov) - P2/3; N=440; Active, not recruiting; Sponsor: Amzell; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed