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

Condition(s) targeted: Tendonitis; Bursitis

Intervention: Ketoprofen Topical Patch 20% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
PPD, Principal Investigator, Affiliation: PPD Austin, TX

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Average pain intensity during daily activities

Secondary outcome:

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

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 (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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

PPD, Austin, Texas 78704, United States

Starting date: June 2006
Ending date: March 2007
Last updated: April 24, 2008