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Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis

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ClinicalTrials.gov Identifier: NCT00352625
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : August 14, 2008
Sponsor:
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 tendonitis or bursitis of the shoulder, elbow or knee.

Condition or disease Intervention/treatment Phase
Tendonitis Bursitis Drug: Ketoprofen Topical Patch 20% Phase 3

Detailed Description:
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. Eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 21 days. Patients will return to the clinic for assessments on Day 3, Day 7, Day 14 and Day 21; a follow-up assessment will be conducted by telephone on Day 35. At each visit through Day 21, patients will rate their average pain intensity during daily activities and while at rest using the 11-point scale (range 0 to 10), and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as prn rescue medication.

Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee
Study Start Date : June 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bursitis
Drug Information available for: Ketoprofen




Primary Outcome Measures :
  1. Average pain intensity during daily activities

Secondary Outcome Measures :
  1. Average pain intensity while at rest
  2. Functional disability
  3. Use of prn rescue medication
  4. Quality of sleep
  5. 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
Criteria

Inclusion

  • Males or females 18 years of age or older
  • Diagnosis of tendonitis or bursitis of the shoulder, elbow or knee
  • Meet pain entry criteria
  • Willing to discontinue use of any pain medication not provided by the study

Exclusion:

  • Have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery
  • Have received corticosteroids in the 30 days preceding screening
  • Have a history or physical examination finding that is incompatible with safe participation in the study
  • Have a history or physical examination finding that is incompatible with study product use
  • Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
  • Are taking medications that may significantly affect renal function

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 ClinicalTrials.gov identifier (NCT number): NCT00352625


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

ClinicalTrials.gov Identifier: NCT00352625     History of Changes
Other Study ID Numbers: EN3269-302
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008

Keywords provided by Endo Pharmaceuticals:
Tendonitis
Bursitis
Pain
Shoulder Pain
Elbow Pain
Knee Pain
Tendon Injury
Muscle, Bone and Cartilage Disorders

Additional relevant MeSH terms:
Tendinopathy
Bursitis
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Joint Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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