Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
Primary Purpose
Tendonitis, Bursitis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketoprofen Topical Patch 20%
Sponsored by
About this trial
This is an interventional treatment trial for Tendonitis focused on measuring Tendonitis, Bursitis, Pain, Shoulder Pain, Elbow Pain, Knee Pain, Tendon Injury, Muscle, Bone and Cartilage Disorders
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
Sites / Locations
- PPD
Outcomes
Primary Outcome Measures
Average pain intensity during daily activities
Secondary Outcome Measures
Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00426985
Brief Title
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
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 Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
Sufficient number of subjects accrued to conduct analysis
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
October 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendonitis, Bursitis
Keywords
Tendonitis, Bursitis, Pain, Shoulder Pain, Elbow Pain, Knee Pain, Tendon Injury, Muscle, Bone and Cartilage Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ketoprofen Topical Patch 20%
Primary Outcome Measure Information:
Title
Average pain intensity during daily activities
Secondary Outcome Measure Information:
Title
Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PPD
Organizational Affiliation
PPD
Official's Role
Study Director
Facility Information:
Facility Name
PPD
City
Austin,
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
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