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AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

NCT03691844 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2020-10-06

Study results available
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Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week trial of a formulation of AMZ001 once or twice daily versus placebo twice daily, including a single-blind treatment group with a commercial gel four times daily.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

AMZ001

diclofenac gel

DRUG

Placebo

Placebo

DRUG

Comparator

diclofenac gel

Sponsors & Collaborators

  • 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
2018-10-04
Primary Completion
2019-07-09
Completion
2019-07-09
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT03691844 on ClinicalTrials.gov