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

Last updated: August 13, 2008
Sponsor: Endo Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Bursitis

Tendon Injuries

Sprains

Treatment

N/A

Clinical Study ID

NCT00426985
EN3269-304
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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 safeparticipation in the study

  • Have a history or physical examination finding that is incompatible with study productuse

  • Are taking medications or other substances contraindicated due to the nature of thestudy medication or the potential for drug interactions.

  • Are taking medications that may significantly affect renal function

Study Design

Total Participants: 330
Study Start date:
January 01, 2007
Estimated Completion Date:
October 31, 2008

Study 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.

Connect with a study center

  • PPD

    Austin,, Texas
    United States

    Site Not Available

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