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A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

NCT06693648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2026-05-07

No results posted yet for this 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.

Conditions

  • Osteoarthritis of Knee
  • Osteoarthritis, Knee

Interventions

DRUG

AMZ001 Diclofenac gel

Diclofenac gel applied once daily

DRUG

Placebo gel

Matching placebo gel applied once daily

Sponsors & Collaborators

  • NBCD A/S

    collaborator INDUSTRY

  • Amzell

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-18
Primary Completion
2025-12-22
Completion
2026-04-13
FDA Drug
Yes

Countries

  • United States
  • China
  • Czechia
  • Denmark
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06693648 on ClinicalTrials.gov