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
1 other identifier
interventional
1,164
1 country
44
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
Shorter than P25 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
June 28, 2017
CompletedJune 28, 2017
July 1, 2016
7 months
November 3, 2015
April 18, 2017
May 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Diclofenac Sodium gel, 1%
EXPERIMENTALapply gel to the target knee
Voltaren® Gel
ACTIVE COMPARATORapply gel to the target knee
Placebo
PLACEBO COMPARATORapply gel to the target knee
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- OA Symptoms for at least 6 months prior to screening.
- Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of \> 9 on a 20 point scale for the target knee immediately prior to randomization.
You may not qualify if:
- History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
- History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
- History of gastrointestinal bleeding or peptic ulcer disease.
- Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
- Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
- Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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 10
Fort Lauderdale, Florida, United States
Glenmark Investigational Site 41
Hialeah, Florida, 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 Site 37
Ormond Beach, Florida, 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 8
Evanston, Illinois, United States
Glenmark Investigational Site 43
Newburgh, Indiana, United States
Glenmark Investigational Site 38
Wichita, Kansas, United States
Glenmark Investigational Site 17
New Orleans, Louisiana, United States
Glenmark Investigational Site 22
Saginaw, Michigan, United States
Glenmark Investigational Site 14
St Louis, Missouri, United States
Glenmark Investigational Site 9
Englewood, Ohio, United States
Glenmark Investigational Site7
Altoona, Pennsylvania, United States
Glenmark Investigational Site 36
Knoxville, Tennessee, United States
Glenmark Investigational Site 39
Nashville, Tennessee, United States
Glenmark Investigational Site 23
Beaumont, Texas, United States
Glenmark Investigational Site 20
Bryan, Texas, United States
Glenmark Investigational Site 34
Dallas, Texas, United States
Glenmark Investigational Site 35
Houston, Texas, United States
Glenmark Investigational Site 44
Houston, Texas, United States
Glenmark Investigational Site 4
Lampasas, Texas, United States
Glenmark Investigational Site 29
San Antonio, Texas, United States
Glenmark Investigational Site 6
San Antonio, Texas, United States
Glenmark Investigational Site 16
Charlottesville, Virginia, United States
Glenmark Investigational Site12
Midlothian, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cathy Tyrrell
- Organization
- Glenmark Pharmaceuticals Ltd
Study Officials
- STUDY DIRECTOR
Mahesh V Deshpande
Glenmark Pharmaceuticals Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 4, 2015
Study Start
August 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
June 28, 2017
Results First Posted
June 28, 2017
Record last verified: 2016-07