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A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03172780
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : July 24, 2018
Mylan Pharmaceuticals
Information provided by (Responsible Party):
Mylan Inc.

Brief Summary:

This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.

Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria

Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Diclofenac sodium gel 1% Drug: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% Drug: Placebo gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Three-arm, Parallel, Placebocontrolled, Clinical Study to Evaluate the Bioequivalence Using Clinical Endpoint of Diclofenac Sodium Gel, 1% (Mylan Inc.) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc.) in Patients With Osteoarthritis (OA) of the Knee
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : December 5, 2017
Actual Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Diclofenac Sodium Gel
Diclofenac Sodium Gel, 1%
Drug: Diclofenac sodium gel 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

Active Comparator: Voltaren® Gel
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Drug: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

Placebo Comparator: Placebo gel
Placebo gel
Drug: Placebo gel
Vehicle Gel 4 gm, 4 times a day for 4 weeks

Primary Outcome Measures :
  1. Mean change in the total WOMAC score [ Time Frame: From baseline to week 4 ]
    Mean change in the total WOMAC pain subscale score for the target knee

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
  • Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
  • After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
  • After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
  • Able to tolerate rescue medication with acetaminophen
  • Subjects who can read and understand WOMAC pain sub scale

Exclusion Criteria:

  • Pregnancy, lactation
  • OA of Kellgren-Lawrence grade 4
  • OA pain in the contralateral knee requiring medication (OTC or prescription)
  • History of OA of either Hip or Hands
  • History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
  • History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
  • History of Drugs or Alcohol abuse within the previous year
  • Symptomatic peripheral vascular disease of the study leg
  • Any musculoskeletal condition
  • Skin disease at the application site
  • Active asthma requiring periodic treatment with systemic steroids
  • Known history of positive HIV, hepatitis C virus, or HBsAg
  • Uncontrolled hypertension
  • History of myocardial infarction, thrombotic events, stroke etc.
  • Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03172780

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Yashoda Hospital - Malakpet
Hyderabad, Andhra Pradesh, India, 500036
Yashoda Hospital -Secunderabad
Secunderabad, Andhra Pradesh, India, 500003
Yashoda Hospital -Somajiguda
Somajiguda, Andhra Pradesh, India, 500082
King George Hospital
Visakhapatnam, Andhra Pradesh, India, 530002
Riddhi Medical Nursing Home
Ahmedabad, Gujarat, India, 380008
Rathi Hospital
Ahmedabad, Gujarat, India, 380015
Sanjivani Superspeciality Hospital Pvt. Ltd
Ahmedabad, Gujarat, India, 380015
B.J Medical College & Civil Hospital
Ahmedabad, Gujarat, India, 380016
GMERS Medical College & Civil Hospital
Ahmedabad, Gujarat, India, 380061
SSG Hospital and Medical College
Baroda, Gujarat, India, 39000
Medistar Multispeciality Hospital
Himmatnagar, Gujarat, India, 383001
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, India, 360005
Anand Multispeciality Hospital
Vadodara, Gujarat, India, 390016
Parul Sevashram Hospital
Vadodara, Gujarat, India, 391760
Omega Hospital
Mangalore, Karnataka, India, 575002
Mysore Medical College and Research Institute
Mysore, Karnataka, India, 570001
Sree Narayana Institute of Medical Science
Ernakulam, Kerala, India, 683594
Sir J. J. Group of Hospital and Grant Government Hospital
Mumbai, Maharashtra, India, 400008
Lokmanya Tilak Municipal Medical College & General Hospital
Mumbai, Maharashtra, India, 400022
Government Medical College and Hospital
Nagpur, Maharashtra, India, 440003
Jasleen Hospital
Nagpur, Maharashtra, India, 440012
Institute of Medical sciences and Lata Mangeshkar
Nagpur, Maharashtra, India, 600001
Supe Heart and Diabetes Hospital & Research Centre
Nashik, Maharashtra, India, 422002
BJ medical college & Sassoon General Hospital
Pune, Maharashtra, India, 411001
Sancheti Institute for Orthopedics & Rehabilitation
Pune, Maharashtra, India, 411005
BhaktiVedanta Hospital and Research Institute
Thane, Maharashtra, India, 401107
IMS and SUM Hospital
Bhubaneshwar, Odisha, India, 751003
Govt Stanley Medical College & Hospital
Chennai, Tamil Nadu, India, 600001
M.V. Hospital & Research Centre
Lucknow, Uttar Pradesh, India, 226003
Ajanta Research Centre
Lucknow, Uttar Pradesh, India, 226005
OM surgical Centre and Maternity Home
Varanasi, Uttar Pradesh, India, 221007
Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics
Kolkata, West Bengal, India, 700020
Sponsors and Collaborators
Mylan Inc.
Mylan Pharmaceuticals

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Responsible Party: Mylan Inc. Identifier: NCT03172780     History of Changes
Other Study ID Numbers: MYL-1601N-3002
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action