NCT02596451

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).

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,164 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium gel, 1%
DRUG	Voltaren® Gel
DRUG	Placebo

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-11-04
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

44 sites across 1 country: United States