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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Placebo; Drug: Diclofenac Sodium gel, 1%; Drug: Voltaren® Gel

• Study Type: Interventional
• Enrollment (Actual): 1164
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Sodium gel, 1%; apply gel to the target knee	Drug: Diclofenac Sodium gel, 1%
Active Comparator: Voltaren® Gel; apply gel to the target knee	Drug: Voltaren® Gel
Placebo Comparator: Placebo; apply gel to the target knee	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee	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.	Baseline and week 4

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Investigators: Study Director: Mahesh V Deshpande, Glenmark Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: GLK-1402