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

This study has been completed.
Information provided by:
Nuvo Research Inc. Identifier:
First received: April 21, 2005
Last updated: January 4, 2007
Last verified: January 2007
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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.

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00108992

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United States, Virginia
Hamptom Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502-9921
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Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Nuvo Research Inc.
  More Information Identifier: NCT00108992     History of Changes
Other Study ID Numbers: PEN-03-112
Study First Received: April 21, 2005
Last Updated: January 4, 2007

Keywords provided by Nuvo Research Inc.:
topical NSAID
topical diclofenac

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017