Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

December 13, 2007 updated by: Novartis

A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 33608
        • Coastal Clinical Research Inc
      • Tallassee, Alabama, United States, 36078
        • River Region Research, LLC
    • Arizona
      • Chandler, Arizona, United States, 85224
        • East Valley Family Physicians
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
    • Arkansas
      • Arkansas City, Arkansas, United States, 67005
        • Heartland Research Associates LLC
    • California
      • Beverly Hills, California, United States, 92011
        • Lovelace Scientific Research, Inc.
      • Carmichael, California, United States, 95608
        • MED Investigations
      • Fair Oaks, California, United States, 95628
        • Med Investigations, Inc.
      • Fresno, California, United States, 93703
        • Universal BioPharma Research, Inc.
      • Santa Barbara, California, United States, 93108
        • Santa Barbara Clinical Research, Inc
      • Santa Maria, California, United States, 93454
        • Pacific Arthritis Center Medical Group
    • Connecticut
      • Stratford, Connecticut, United States, 06615
        • Clinical Research Consultants, LLC
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Seidman Clinical Trials
      • Gainesville, Florida, United States, 32607
        • Florida Medical Research Institute
      • Hollywood, Florida, United States, 33023
        • South Florida Clinical Research Center
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Largo, Florida, United States, 33774
        • Suncoast Internal Medicine Consultants
      • Miami, Florida, United States, 33155
        • AppleMed Research, Inc.
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Opa Locka, Florida, United States, 33056
        • Sunshine Research Center, LLC
      • Ormond Beach, Florida, United States, 32174
        • Peninsula Research, Inc.
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc.
      • Pembroke Pines, Florida, United States, 33028
        • Andres Patron DO PA
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research - St Petersburg
      • Plantation, Florida, United States, 33324
        • Sunrise Medical Research
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research
      • Stuart, Florida, United States, 34996
        • Radiant Research
    • Idaho
      • Boise, Idaho, United States, 83702
        • Intermountain Orthopaedics
    • Indiana
      • Munster, Indiana, United States, 46321
        • Medical Specialists Clinical Research Center
    • Kansas
      • Newton, Kansas, United States, 67114
        • Heartland Research Associates, LLC
      • Wichita, Kansas, United States, 67205
        • Heartland Research Associates, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Best Clinical Trial, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • Peter A. Holt, MD
      • Wheaton, Maryland, United States, 20902
        • The Center For Rheumatology And Bone Research
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Phase III Clinical Research
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Professional Clinical Research, Inc
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Twin Cities Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research
      • St. Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Internal Medical Associates
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • South Jersey Medical Associates, PA
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • North Carolina Arthritis & Allergy Care Center
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc
      • Columbus, Ohio, United States, 43212
        • Radiant Research
      • Mogadore, Ohio, United States, 44260
        • Radiant Research, Inc. - Akron
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Neshaminy Medical, PC
      • Erie, Pennsylvania, United States, 16506
        • Westminster Family Medicine
      • Feasterville, Pennsylvania, United States, 19053
        • Feasterville Family Health Care Center
      • Havertown, Pennsylvania, United States, 19083
        • Southeastern Pennsylvania Medical Institute
      • Philadelphia, Pennsylvania, United States, 19115
        • Radiant Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Radiant Research - Anderson
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research
      • Austin, Texas, United States, 78705
        • Walter F. Chase, M.D., P.A.
      • Dallas, Texas, United States, 75231
        • Radiant Research Dallas North
      • San Antonio, Texas, United States, 78209
        • Quality Research, Inc.
      • San Antonio, Texas, United States, 78229
        • Radiant Research - San Antonio
      • Sugar Land, Texas, United States, 77479
        • Texas Research Center, LLP
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
      • Virginia Beach, Virginia, United States, 23451
        • Tidewater Integrated Medical Research
    • Washington
      • Spokane, Washington, United States, 99204
        • The Physicians Clinic of Spokane
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Osteoarthritis of the knee

Exclusion Criteria:

  • Other rheumatic disease, such as rheumatoid arthritis
  • Active gastrointestinal ulcer during the last year
  • Known allergy to analgesic drugs
  • Other protocol defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Diclofenac Sodium Gel
4 grams per knee, 4 times per day, for 12 weeks
Placebo Comparator: 2
Drug: Placebo
4 grams per knee, 4 times per day, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pain in the target knee (WOMAC pain index);
functional capacity in the target knee (WOMAC function index); and
global rating of benefit (100 mm Visual Analogue Scale, VAS).

Secondary Outcome Measures

Outcome Measure
Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
Low pain intensity in either knee; and
Low functional impairment in either knee.
Safety of Diclofenac Sodium Gel 1% assessed by:
monitoring adverse events; and
laboratory evaluations.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Principal Investigator: Roy Altman, MD, University of California, in Los Angeles, Division of Rheumatology, 310 206 7866

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 24, 2007

First Submitted That Met QC Criteria

January 24, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 13, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOSG-PN-316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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