NCT02121002

Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee

A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,176 (actual)
• Sponsor: Amneal Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium Topical Gel, 1%	Opaque, white gel
DRUG	Voltaren Topical Gel, 1%	Opaque, white gel
DRUG	Vehicle Diclofenac Sodium Topical Gel	Opaque, white gel

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-04-23
• Last updated: 2021-06-16
• Results posted: 2021-06-16

Locations

22 sites across 1 country: India