Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis

Completed · Phase 3

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT00108992

Run by

Nuvo Research Inc.

People needed

750

Starts

2004-02-01

Expected to finish

2005-09-01

Last updated by the study team

2007-01-05

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Coastal Clinical Research — Mobile, Alabama, United States
• Redpoint Research — Phoenix, Arizona, United States
• OMC Clinical — Beverly Hills, California, United States
• Associated Pharmaceutical Research — Buena Park, California, United States
• Med Investigators — Fair Oaks, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Boling Clinical Trials — Upland, California, United States
• Tampa Bay Medical Research Inc. — Clearwater, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Medisphere Medical Research — Evansville, Indiana, United States
• Synergy Medical Education Alliance — Saginaw, Michigan, United States
• Redrock Research Center — Las Vegas, Nevada, United States
• Partners in Primary Care — Voorhees Township, New Jersey, United States
• Camp Hill Clinical Research Center — Camp Hill, Pennsylvania, United States
• Primary Physicians Research — Pittsburgh, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• Clinical Research Associates — Nashville, Tennessee, United States
• Research Across America — Dallas, Texas, United States
• Sam Clinical Research Center — San Antonio, Texas, United States
• Hamptom Roads Center for Clinical Research — Norfolk, Virginia, United States
• National Clinical Research — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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