Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00171665

First received: September 13, 2005

Last updated: October 9, 2006

Last verified: October 2006

History of Changes

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 topical sodium gel 1%	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

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:	December 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: NCT00171665

Show 70 Study Locations

Sponsors and Collaborators

Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. Epub 2010 Jan 11.

Altman RD, Dreiser RL, Fisher CL, Chase WF, Dreher DS, Zacher J. Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009 Sep;36(9):1991-9. Epub 2009 Jul 31.

ClinicalTrials.gov Identifier:	NCT00171665 History of Changes
Other Study ID Numbers:	VOSG-PE-315
Study First Received:	September 13, 2005
Last Updated:	October 9, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hand osteoarthritis, Topical NSAID, Diclofenac sodium

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013

To Top