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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00365586
First received: August 16, 2006
Last updated: August 13, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Osteoarthritis
Drug: Ketoprofen Topical Patch , 20%
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

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

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

Estimated Enrollment: 300
Study Start Date: August 2006
Study Completion Date: May 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00365586

Locations
United States, Texas
PPD
Austin, Texas, United States, 78704
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Principal Investigator: PPD PPD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00365586     History of Changes
Other Study ID Numbers: EN3269-303
Study First Received: August 16, 2006
Last Updated: August 13, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Pain
Osteoarthritis
Knee
NSAID

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ketoprofen
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 September 18, 2014