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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Tendonitis, Bursitis

Intervention / Treatment
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* Drug: Ketoprofen Topical Patch 20%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketoprofen Topical Patch 20%|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain intensity during daily activities |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tendonitis, Bursitis, Pain, Shoulder Pain, Elbow Pain, Knee Pain, Tendon Injury, Muscle, Bone and Cartilage Disorders