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To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).

NCT02596451 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1164

Last updated 2017-06-28

Study results available
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Summary

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee

Conditions

Interventions

DRUG

Diclofenac Sodium gel, 1%

DRUG

Voltaren® Gel

DRUG

Placebo

Sponsors & Collaborators

  • Glenmark Pharmaceuticals Ltd. India

    lead INDUSTRY

Principal Investigators

  • Mahesh V Deshpande · Glenmark Pharmaceuticals Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02596451 on ClinicalTrials.gov