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).

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596451
• Other study ID #: GLK-1402
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2015
• Last updated: July 6, 2016
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Health authority: US: Food and Drug Administration (FDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1410
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

1. Healthy male or non-pregnant female aged = 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria.

2. OA Symptoms for at least 6 months prior to screening.

3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20 point scale for the target knee immediately prior to randomization.

Exclusion Criteria:

1. History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.

2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.

3. History of gastrointestinal bleeding or peptic ulcer disease.

4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).

5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.

6. Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Diclofenac Sodium gel, 1%

• Voltaren® Gel

• Placebo

Locations

Country	Name	City	State
United States	Glenmark Investigational Site7	Altoona	Pennsylvania
United States	Glenmark Investigational Site 1	Anaheim	California
United States	Glenmark Investigational Site 21	Anaheim	California
United States	Glenmark Investigational Site 31	Anaheim	California
United States	Glenmark Investigational Site 23	Beaumont	Texas
United States	Glenmark Investigational Site 20	Bryan	Texas
United States	Glenmark Investigational Site 26	Canoga Park	California
United States	Glenmark Investigational Site 42	Carlsbad	California
United States	Glenmark Investigational Site 30	Carmichael	California
United States	Glenmark Investigational Site 33	Cerritos	California
United States	Glenmark Investigational Site 16	Charlottesville	Virginia
United States	Glenmark Investigational Site 34	Dallas	California
United States	Glenmark Investigational Site 25	El Cajon	California
United States	Glenmark Investigational Site 9	Englewood	Ohio
United States	Glenmark Investigational Site 8	Evanston	Illinois
United States	Glenmark Investigational Site 10	Fort Lauderdale	Florida
United States	Glenmark Investigational Site 41	Hialeah	Florida
United States	Glenmark Investigational Site 35	Houston	Texas
United States	Glenmark Investigational Site 44	Houston	Texas
United States	Glenmark Investigational Site 36	Knoxville	Texas
United States	Glenmark Investigational Site 24	La Mesa	California
United States	Glenmark Investigational Site 4	Lampasas	Texas
United States	Glenmark Investigational Site 5	Mesa	Arizona
United States	Glenmark Investigational Site 15	Miami	Florida
United States	Glenmark Investigational Site 19	Miami	Florida
United States	Glenmark Investigational Site 28	Miami	Florida
United States	Glenmark Investigational Site 32	Miami	Florida
United States	Glenmark Investigational Site 40	Miami	Florida
United States	Glenmark Investigational Site 3	Miami Lakes	Florida
United States	Glenmark Investigational Site12	Midlothian	Virginia
United States	Glenmark Investigational Site 39	Nashville	Tennessee
United States	Glenmark Investigational Site 17	New Orleans	Louisiana
United States	Glenmark Investigational Site 43	Newburgh	Indiana
United States	Glenmark Investigational Site 37	Ormond Beach	Tennessee
United States	Glenmark Investigational Site 2	Pasadena	California
United States	Glenmark Investigational Site 13	Rancho Cucamonga	California
United States	Glenmark Investigational Site 27	Sacramento	California
United States	Glenmark Investigational Site 22	Sagniaw	Michigan
United States	Glenmark Investigational Site 29	San Antonio	Texas
United States	Glenmark Investigational Site 6	San Antonio	Texas
United States	Glenmark Investigational Site 14	St. Louis	Missouri
United States	Glenmark Investigational Site 11	West Palm Beach	Florida
United States	Glenmark Investigational Site 18	West Palm Beach	Florida
United States	Glenmark Investigational Site 38	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in the total WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain subscale score for the target knee, from baseline to week 4		week 4	No