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

Bursitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00426985
• Other study ID #: EN3269-304
• Status: Terminated
• Phase: Phase 3
• First received: January 24, 2007
• Last updated: August 13, 2008
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2008
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 330
• Est. completion date: October 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bursitis
• Tendonitis

Intervention

Drug:
• Ketoprofen Topical Patch 20%

Locations

Country	Name	City	State
United States	PPD	Austin,	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average pain intensity during daily activities
Secondary	Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep