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

This study has been terminated.
(Sufficient number of subjects accrued to conduct analysis)
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00426985
First received: January 24, 2007
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 tendonitis or bursitis of the shoulder, elbow or knee


Condition Intervention Phase
Tendonitis
Bursitis
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 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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Average pain intensity during daily activities

Secondary Outcome Measures:
  • Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep

Estimated Enrollment: 330
Study Start Date: January 2007
Estimated Study Completion Date: October 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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 (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. The use of study treatment and rescue medication will be recorded in the diary each day. 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 tendonitis or bursitis of the shoulder, elbow or knee
  • Meet pain entry criteria
  • Willing to discontinue use of any pain medication not provided by study

Exclusion Criteria:

  • 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
  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: NCT00426985

Locations
United States, Texas
PPD
Austin,, Texas, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: PPD PPD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426985     History of Changes
Other Study ID Numbers: EN3269-304
Study First Received: January 24, 2007
Last Updated: August 13, 2008
Health Authority: United States: Food and Drug Administration

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:
Bursitis
Tendinopathy
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Ketoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014