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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Diclofenac Sodium Topical Gel, 1%; Drug: Voltaren Topical Gel, 1%; Drug: Vehicle Diclofenac Sodium Topical Gel

• Study Type: Interventional
• Enrollment (Actual): 1176
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Goa, India, 403716
    • Goa Medical College
  • Andhra Pradesh
    • Secunderabad, Andhra Pradesh, India, 500003
      • Sunshine Hospitals
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • King George Hospital
  • Andra Pradesh
    • Visakhapatnam, Andra Pradesh, India, 530002
      • King George Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 015
      • Rathi Orthopedic and Research Centre
    • Ahmedabad, Gujarat, India, 380016
      • B. J. Medical College & Hospital
    • Ahmedabad, Gujarat, India, 380061
      • GMERS Medical College and Hospital
    • Junagadh, Gujarat, India, 362 001
      • Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra
    • Vadodara, Gujarat, India, 390007
      • Centre For Knee Surgery
  • Gujurat
    • Rajkot, Gujurat, India, 360007
      • Shree Giriraj Multispeciality Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • St Johns Medical College
    • Belgaum, Karnataka, India, 590010
      • K L E Societys Jawaharlal Nehry Medical College
    • Mysore, Karnataka, India, 570001
      • Mysore Medical College
  • Kerala
    • Calicut, Kerala, India, 673008
      • Government Medical College, Calicut
  • Maharashtra
    • Mumbai, Maharashtra, India, 400022
      • Psm Dept Ltmmc & Ltmg Hospital
    • Nagpur, Maharashtra, India, 440009
      • Government Medical College
    • Nagpur, Maharashtra, India, 440010
      • Jasleen Hospital
    • Nagpur, Maharashtra, India, 440019
      • Lata Mangeshkar Hospital
    • Pune, Maharashtra, India, 411001
      • BJ Medical College
  • Rajasthan
    • Jaipur, Rajasthan, India, 302023
      • Malpani Multispeciality Hospital
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625020
      • Apollo Speciality Hospitals
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226 003
      • M V Hospital and Research Centre
    • Lucknow, Uttar Pradesh, India, 226003
      • King Georges Medical University

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:

• Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.
• Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
• After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee
• If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study
• Able to tolerate rescue medication with paracetamol/acetaminophen.

Exclusion Criteria:

• Pregnant or lactating or planning to become pregnant during the study period.
• X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
• History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
• After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
• History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.
• History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
• History of gastrointestinal bleeding or peptic ulcer disease.
• Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
• Elevated transaminases at screening.
• Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization.
• Concomitant use of corticosteroids or use within 30 days of study randomization.
• Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
• Known allergy to aspirin or nonsteroidal anti-inflammatory drug
• Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.
• Receipt of any drug as part of a research study within 30 days prior to screening.
• Previous participation in this study.
• Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
• Recent history of major knee injury or surgery.
• Known history of positive HIV

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Sodium Topical Gel, 1%; Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks	Drug: Diclofenac Sodium Topical Gel, 1%; Opaque, white gel
Active Comparator: Voltaren Topical Gel, 1%; Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks	Drug: Voltaren Topical Gel, 1%; Opaque, white gel
Placebo Comparator: Vehicle Diclofenac Sodium Topical Gel; Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks	Drug: Vehicle Diclofenac Sodium Topical Gel; Opaque, white gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to 4 Weeks in WOMAC Pain Score	Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4	Baseline and Week 4

Collaborators and Investigators

• Sponsor: Amneal Pharmaceuticals, LLC
• Collaborators: Sristek Clinical Research Solutions Limited
• Investigators: Study Director: Prayag Shah, MD, Amneal Pharmaceuticals, LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: April 21, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; 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: AM-DCG-001