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A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

NCT03172780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2022-03-03

Study results available
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Summary

This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.

Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria

Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Diclofenac sodium gel 1%

Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

DRUG

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

DRUG

Placebo gel

Vehicle Gel 4 gm, 4 times a day for 4 weeks

Sponsors & Collaborators

  • Mylan Pharmaceuticals Private Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2017-12-05
Completion
2017-12-05
FDA Drug
Yes

Countries

  • India

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 NCT03172780 on ClinicalTrials.gov