Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171652

Purpose

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

Condition	Intervention	Phase
Osteoarthritis	Drug: Diclofenac sodium gel 1%	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	360
Study Start Date:	May 2005
Estimated Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171652

Show 48 Study Locations

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	VOSG-PE-314
Study First Received:	September 13, 2005
Last Updated:	October 9, 2006
ClinicalTrials.gov Identifier:	NCT00171652
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Hand osteoarthritis, Topical NSAID, Diclofenac sodium

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Diclofenac
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009