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

NCT ID: NCT00426985

Last Updated: 2008-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-10-31

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

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.

Conditions

Tendonitis; Bursitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Ketoprofen Topical Patch 20%

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

PPD

Role: STUDY_DIRECTOR

PPD Development, LP

Locations

PPD

Austin, Texas, United States

Countries

United States

Other Identifiers

EN3269-304

Identifier Type: -

Identifier Source: org_study_id