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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00108992
Recruitment Status : Completed
First Posted : April 22, 2005
Last Update Posted : January 5, 2007
Information provided by:
Nuvo Research Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Diclofenac, topical Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. pain
  2. physical function
  3. patient overall health assessment

Secondary Outcome Measures :
  1. stiffness
  2. patient global assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00108992

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Hamptom Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502-9921
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Sponsors and Collaborators
Nuvo Research Inc. Identifier: NCT00108992     History of Changes
Other Study ID Numbers: PEN-03-112
First Posted: April 22, 2005    Key Record Dates
Last Update Posted: January 5, 2007
Last Verified: January 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