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

Phase 3

Completed

• Conditions: Tendonitis; Bursitis

• Registration Number: NCT00352625
• Lead Sponsor: APR Applied Pharma Research s.a.

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 (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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-14
• Primary Completion: 2007-02
• Study Completion: 2007-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average pain intensity during daily activities

Secondary Outcome Measures

Name	Time	Method
Average pain intensity while at rest
Use of prn rescue medication
Quality of sleep
Functional disability
Patient's and physician's global assessments of study medication

Trial Locations

Locations (1)

PPD; 🇺🇸 Austin, Texas, United States