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).

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Voltaren® Gel; Drug: Diclofenac Sodium gel, 1%; Drug: Placebo

• Registration Number: NCT02596451
• Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-07
• Results First Submitted: 2017-04-18
• Results First Submitted QC: 2017-05-26
• Last Update Submitted: 2017-05-26
• Results First Posted: 2017-06-28
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1164

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voltaren® Gel	Voltaren® Gel	apply gel to the target knee
Diclofenac Sodium gel, 1%	Diclofenac Sodium gel, 1%	apply gel to the target knee
Placebo	Placebo	apply gel to the target knee

Primary Outcome Measures

Name	Time	Method
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee	Baseline and week 4	The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.

Trial Locations

Locations (44)

Glenmark Investigational Site 5; 🇺🇸 Mesa, Arizona, 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 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 25; 🇺🇸 El Cajon, California, United States

Glenmark Investigational Site 24; 🇺🇸 La Mesa, California, United States

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