Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis - Full Text View

Sponsor:	Nuvo Research Inc.
Information provided by:	Nuvo Research Inc.
ClinicalTrials.gov Identifier:	NCT00108992

Purpose

Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: Diclofenac, topical	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

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 Nuvo Research Inc.:

Primary Outcome Measures:

pain
physical function
patient overall health assessment

Secondary Outcome Measures:

stiffness
patient global assessment

Estimated Enrollment:	750
Study Start Date:	February 2004
Estimated Study Completion Date:	September 2005

Detailed Description:

During this 12-week study, patients will visit the study clinic 5 times. At the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical examination performed. After washout of all NSAIDs/other analgesic medication, the patient will return for the baseline visit. During the treatment phase of the study, the patient will apply a topical solution to his/her osteoarthritic knee and take an oral study tablet. The patient may randomly receive active treatment with topical diclofenac, oral diclofenac, both, or neither (placebo). Follow-up clinic visits are conducted at 4, 8 and 12 weeks. Routine laboratory analyses are done at baseline, 4 and 12 weeks.

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary osteoarthritis of the knee, verified radiographically
Moderate flare of pain in the knee after washout of stable therapy
If female, non-pregnant
Ability to swallow moderately-sized tablets

Exclusion Criteria:

Secondary osteoarthritis of the knee
Major knee surgery at any time, or minor knee surgery in previous year
Severe uncontrolled heart, liver or kidney disease
Ulcer or bleeding from the stomach
Corticosteroid use
Fibromyalgia
Skin disorder of the knee

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108992

Locations

United States, Alabama
Coastal Clinical Research
Mobile, Alabama, United States, 36608
United States, Arizona
Redpoint Research
Phoenix, Arizona, United States, 85029
United States, California
OMC Clinical
Beverly Hills, California, United States, 90211
Associated Pharmaceutical Research
Buena Park, California, United States, 90620
Med Investigators
Fair Oaks, California, United States, 95628
Desert Medical Advances
Palm Desert, California, United States, 92260
Boling Clinical Trials
Upland, California, United States, 91786
United States, Florida
Tampa Bay Medical Research Inc.
Clearwater, Florida, United States, 33761
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Indiana
Medisphere Medical Research
Evansville, Indiana, United States, 47714
United States, Michigan
Synergy Medical Education Alliance
Saginaw, Michigan, United States, 48602
United States, Nevada
Redrock Research Center
Las Vegas, Nevada, United States, 89146
United States, New Jersey
Partners in Primary Care
Voorhees, New Jersey, United States, 08043
United States, Pennsylvania
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, United States, 17011
Primary Physicians Research
Pittsburgh, Pennsylvania, United States, 15241
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Clinical Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Sam Clinical Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Hamptom Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502-9921
National Clinical Research
Richmond, Virginia, United States, 23294

Sponsors and Collaborators

Nuvo Research Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00108992 History of Changes
Other Study ID Numbers:	PEN-03-112
Study First Received:	April 21, 2005
Last Updated:	January 4, 2007
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Nuvo Research Inc.:

topical NSAID
topical diclofenac

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