Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Condition(s) targeted: Osteoarthritis

Intervention: Diclofenac topical sodium gel 1% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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

Official title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

OA pain intensity in target hand at Week 4 and 6

Total AUSCAN score in target hand at Week 4 and 6

Global rating of disease activity by patient at Week 4 and 6

Secondary outcome:

OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8

AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8

OA pain intensity in target hand and use of rescue medication recorded in diary

Global evaluation of treatment at final visit

Treatment responder rate according to OARSI criteria

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key Inclusion criteria:

• Osteoarthritis of the hand

Key Exclusion Criteria:

- Other rheumatic disease, such as rheumatoid arthritis

- Active gastrointestinal ulcer during the last year

- Known allergy to analgesic drugs

Montgomery Rheumatology Associates, Montgomery, Alabama 36111, United States

Drug Research & Analysis Corp, Montgomery, Alabama 36124, United States

Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States

MedSearch, LLC, Calera, Alabama 35040, United States

Arizona Center for Clinical Research, Glendale, Arizona 85306, United States

Quality of Life Medical Research Center, LLC, Tucson, Arizona 85712, United States

Med Investigations/Med Center, Carmichael, California 95608, United States

Lovelace Scientific Resources, Inc., Beverly Hills, California 90211, United States

H. Richard Barthel,MD, Inc., Santa Barbara, California 93105, United States

Clinical Research Consultants, Stratford, Connecticut 06615, United States

Arthritis & Osteoporosis Center, PC, Hamden, Connecticut 06518, United States

Allergy and Arthritis Associates, Hamden, Connecticut 06518, United States

Clinical Research of CT/NY, Danbury, Connecticut 06810, United States

Health Core, Newark, Delaware 19713, United States

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

University Neurology, Sarasota, Florida 34243, United States

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

Southwest Florida Clinical Research Center, Tampa, Florida 33609, United States

The Community Research of South Florida, Hialeah, Florida 33013, United States

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

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

Arthritis Research of Florida, Inc., Palm Harbor, Florida 34684, United States

Miami Research Associates, Miami, Florida 33173, United States

Clinical Research of West Florida, Clearwater, Florida 33765, United States

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

Radiant Research - Atlanta West, Atlanta, Georgia 30308, United States

Intermountain Orthopaedics, Boise, Idaho 83702, United States

Intermountain Orthopaedics, Boise, Idaho 83702, United States

Allan B. Aven, MD, SC, Arlington Heights, Illinois 60005, United States

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

Chesapeake Medical Research, LLC, Baltimore, Maryland 21239, United States

Arthritis Associates, Inc., Peabody, Massachusetts 01960, United States

Clinsite, Ann Arbor, Michigan 48106, United States

Radiant Research - Minneapolis, Edina, Minnesota 55435, United States

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

PrimeCare Research Associates, Florissant, Missouri 63031, United States

Meridian Clinical Research, LLC, Omaha, Nebraska 68134, United States

Comprehensive Clinical Research, Turnersville, New Jersey 08012, United States

Crescent Medical Research, Salisbury, North Carolina 28144, United States

Unifour Medical Research Associates, Hickory, North Carolina 28601, United States

Carolina Clinical Research, Winston Salem, North Carolina 27103, United States

Clinical Research Source, Perrysburg, Ohio 43551, United States

Wells Institute for Heatlh Awareness, Kettering, Ohio 45429, United States

PRO Research, Eugene, Oregon 97401, United States

Allegheny Pain Management, Altoona, Pennsylvania 16602, United States

Radiant Research - Reading, Wyomissing, Pennsylvania 19610, United States

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

Medical Group @ Marple Commons, Broomall, Pennsylvania 19008, United States

Radiant Research, Philadelphia, Pennsylvania 19115, United States

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

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

Westminster Family Medicine, Erie, Pennsylvania 16506, United States

Partners in Clinical Research, Woonsocket, Rhode Island 02895, United States

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

Palmetto Medical Research, Mt. Pleasant, South Carolina 29464, United States

Harmony Research, Inc., Johnson City, Tennessee 37601, United States

Holston Medical Group, Kingsport, Tennessee 37660, United States

Radiant Research - San Antonio Northeast, San Antonio, Texas 78217, United States

Walter F. Chase, MD, PA, Austin, Texas 78705, 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

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

Intermoutain Clinical Research, Salt Lake City, Utah 84102, United States

Radiant Research - Salt Lake City, Salt Lake City, Utah 84107, United States

Charlottesville Medical Research, Charlottesville, Virginia 22911, United States

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

Radiant Research - Tacoma, Lakewood, Washington 98499, United States

Dean Medical Center - Oregon Clinic, Oregon, Wisconsin 53575, United States

Advanced Healthcare, SC, Milwaukee, Wisconsin 53209, United States

Starting date: May 2005
Ending date: December 2005
Last updated: October 9, 2006