Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee

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: NCT00365586
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : August 14, 2008
Information provided by:
Endo Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Ketoprofen Topical Patch , 20% Phase 3

Detailed Description:

This randomized, double-blind placebo-controlled parallel group study will be conducted with patients who have experienced a flare of osteoarthritis of the knee. At screening, patients whose pain is currently controlled by an analgesic will agree, after giving Informed Consent, to discontinue that analgesic. Eligible patients will be randomized (1:1 ratio) to receive double-blind treatment with either the ketoprofen topical patch or a matching placebo patch to be applied once daily for 28 days. Patients will return to the clinic on Days 7, 14, 21 and 28. At Day 28, patients may choose to open a 2 month open-label period.

Patients will rate their pain using the Knee Injury and Osteoarthritis Outcome Score (KOOS) which contains the WOMAC pain subscale. Patients will also complete an electronic diary in which pain intensity, pain relief, and quality of sleep ratings will be captured. In addition, rescue medication consumption data will be collected. Ibuprofen will be provided as prn rescue medication.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III Study of the Efficacy, Tolerability and Safety of the Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee, Including a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase Followed by an Open-Label Treatment Phase
Study Start Date : August 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Ketoprofen

Primary Outcome Measures :
  1. Pain as measured by the pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at Week 2

Secondary Outcome Measures :
  1. Pain intensity, pain relief (diary)
  2. Functional disability
  3. Use of prn rescue medication
  4. Quality of sleep
  5. Lost days of work
  6. Patient's and physician's global assessments of study medication

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or females 18 years of age or older
  • Diagnosis of osteoarthritis of the knee (unilateral or bilateral)
  • Meet pain entry criteria
  • Willing to discontinue use of all analgesic medications (including over-the-counter [OTC] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.

Exclusion Criteria:

  • Positive urine pregnancy test, pregnant or lactating.
  • Have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or Paget's disease
  • Have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee
  • Have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit
  • Have a history or physical examination finding that is incompatible with safe participation in the study or study product use
  • Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
  • Have significant renal or hepatic impairment
  • Are taking a sleep medication at a dose that has not been stable for at least 3 months

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): NCT00365586

United States, Texas
Austin, Texas, United States, 78704
Sponsors and Collaborators
Endo Pharmaceuticals
Principal Investigator: PPD PPD Identifier: NCT00365586     History of Changes
Other Study ID Numbers: EN3269-303
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008

Keywords provided by Endo Pharmaceuticals:

Additional relevant MeSH terms:
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