Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.

First Received on September 13, 2005. Last Updated on May 29, 2006 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171691

Purpose

This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.

Condition	Intervention	Phase
Osteoarthritis	Drug: Diclofenac Topical Sodium Gel 1%	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety of Diclofenac Sodium Gel in Knee 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:

Incidence of treatment-emergent adverse events
Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12

Secondary Outcome Measures:

Incidence of serious treatment-emergent adverse events
Number of patients who discontinued study medication due to a treatment-emergent adverse event
WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12

Estimated Enrollment:

450

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion criteria

• Osteoarthritis of the knee

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: NCT00171691

Locations

United States, New Jersey
Novartis Consumer Health Inc.
Parsippany, New Jersey, United States

Sponsors and Collaborators

Novartis

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00171691 History of Changes
Other Study ID Numbers:	VOSG-PN-309
Study First Received:	September 13, 2005
Last Updated:	May 29, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Knee osteoarthritis, Topical NSAID, Diclofenac sodium

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
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 February 09, 2012