NCT02913521

Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 934 (actual)
• Sponsor: Akorn, Inc. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium Gel 1%
DRUG	Voltaren Gel
DRUG	Placebo

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2016-09-23
• Last updated: 2021-02-26
• Results posted: 2021-02-26

Locations

51 sites across 6 countries: Estonia, Latvia, Lithuania, Poland, Romania, Ukraine