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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis of the Knee

Intervention: Diclofenac Sodium Gel (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Roy Altman, MD, Principal Investigator, Affiliation: University of California, in Los Angeles, Division of Rheumatology, 310 206 7866

Summary

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

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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:

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.

Eligibility

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Coastal Clinical Research Inc, Mobile, Alabama 33608, United States

River Region Research, LLC, Tallassee, Alabama 36078, United States

East Valley Family Physicians, Chandler, Arizona 85224, United States

HOPE Research Institute, Phoenix, Arizona 85050, United States

Heartland Research Associates LLC, Arkansas City, Arkansas 67005, United States

Lovelace Scientific Research, Inc., Beverly Hills, California 92011, United States

MED Investigations, Carmichael, California 95608, United States

MED Investigations, Inc., Fair Oaks, California 95628, United States

Universal BioPharma Research, Inc., Fresno, California 93703, United States

Santa Barbara Clinical Research, Inc, Santa Barbara, California 93108, United States

Pacific Arthritis Center Medical Group, Santa Maria, California 93454, United States

Clinical Research Consultants, LLC, Stratford, Connecticut 06615, United States

Seidman Clinical Trials, Delray Beach, Florida 33484, United States

Florida Medical Research Institute, Gainesville, Florida 32607, United States

South Florida Clinical Research Center, Hollywood, Florida 33023, United States

Health Awareness, Inc., Jupiter, Florida 33458, United States

Suncoast Internal Medicine Consultants, Largo, Florida 33774, United States

AppleMed Research, Inc., Miami, Florida 33155, United States

Suncoast Clinical Research, Inc., New Port Richey, Florida 34652, United States

Sunshine Research Center, LLC, Opa Locka, Florida 33056, United States

Peninsula Research, Inc., Ormond Beach, Florida 32174, United States

Andres Patron DO PA, Pembroke Pines, Florida 33028, United States

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States

Radiant Research - St Petersburg, Pinellas Park, Florida 33781, United States

Sunrise Medical Research, Plantation, Florida 33324, United States

Coastal Medical Research, Port Orange, Florida 32127, United States

Radiant Research, Stuart, Florida 34996, United States

Intermountain Orthopaedics, Boise, Idaho 83702, United States

Medical Specialists Clinical Research Center, Munster, Indiana 46321, United States

Heartland Research Associates, LLC, Newton, Kansas 67114, United States

Heartland Research Associates, LLC, Wichita, Kansas 67205, United States

Best Clinical Trial, LLC, New Orleans, Louisiana 70115, United States

Peter A. Holt, MD, Baltimore, Maryland 21239, United States

The Center for Rheumatology and Bone Research, Wheaton, Maryland 20902, United States

Phase III Clinical Research, Fall River, Massachusetts 02720, United States

Professional Clinical Research, Inc, Cadillac, Michigan 49601, United States

Twin Cities Clinical Research, Brooklyn Center, Minnesota 55430, United States

The Center for Pharmaceutical Research, Kansas City, Missouri 64114, United States

St. Louis Center for Clinical Research, St. Louis, Missouri 63128, United States

Internal Medical Associates, Grand Island, Nebraska 68803, United States

South Jersey Medical Associates, PA, Blackwood, New Jersey 08012, United States

North Carolina Arthritis & Allergy Care Center, Raleigh, North Carolina 27609, United States

Rapid Medical Research, Inc, Cleveland, Ohio 44122, United States

Radiant Research, Columbus, Ohio 43212, United States

Radiant Research, Inc. - Akron, Mogadore, Ohio 44260, United States

Clinical Research Source, Inc, Perrysburg, Ohio 43551, United States

Neshaminy Medical, PC, Bensalem, Pennsylvania 19020, United States

Westminster Family Medicine, Erie, Pennsylvania 16506, United States

Feasterville Family Health Care Center, Feasterville, Pennsylvania 19053, United States

Southeastern Pennsylvania Medical Institute, Havertown, Pennsylvania 19083, United States

Radiant Research, Philadelphia, Pennsylvania 19115, United States

Omega Medical Research, Warwick, Rhode Island 02886, United States

Radiant Research - Anderson, Anderson, South Carolina 29621, United States

Holston Medical Group, Kingsport, Tennessee 37660, United States

Amarillo Center for Clinical Research, Amarillo, Texas 79124, United States

Walter F. Chase, M.D., P.A., Austin, Texas 78705, United States

Radiant Research Dallas North, Dallas, Texas 75231, United States

Quality Research, Inc., San Antonio, Texas 78209, United States

Radiant Research - San Antonio, San Antonio, Texas 78229, United States

Texas Research Center, LLP, Sugar Land, Texas 77479, United States

Health Research of Hampton Roads, Inc., Newport News, Virginia 23606, United States

Tidewater Integrated Medical Research, Virginia Beach, Virginia 23451, United States

The Physicians Clinic of Spokane, Spokane, Washington 99204, United States

Advanced Healthcare, Milwaukee, Wisconsin 53209, United States

Additional Information

Starting date: November 2006
Last updated: December 13, 2007

Page last updated: August 23, 2015

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