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Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
This study has been completed.
Study NCT00352625   Information provided by Endo Pharmaceuticals
First Received: June 30, 2006   Last Updated: August 13, 2008   History of Changes

June 30, 2006
August 13, 2008
June 2006
February 2007   (final data collection date for primary outcome measure)
Average pain intensity during daily activities
Same as current
Complete list of historical versions of study NCT00352625 on ClinicalTrials.gov Archive Site
  • Average pain intensity while at rest
  • Functional disability
  • Use of prn rescue medication
  • Quality of sleep
  • Patient's and physician's global assessments of study medication
  • Average pain intensity while at rest
  • Functional disability
  • Use of prn rescue medication
  • Quality of sleep
  • Patient’s and physician’s global assessments of study medication
 
Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
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

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.

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Tendonitis
  • Bursitis
Drug: Ketoprofen Topical Patch 20%
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
330
March 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00352625
 
EN3269-302
Endo Pharmaceuticals
 
Principal Investigator: PPD PPD Austin, TX
Endo Pharmaceuticals
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP