Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tendonitis Bursitis |
Drug: Ketoprofen Topical Patch 20% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- Average pain intensity during daily activities
- 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
| Estimated Enrollment: | 330 |
| Study Start Date: | June 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00352625 History of Changes |
| Other Study ID Numbers: | EN3269-302 |
| Study First Received: | June 30, 2006 |
| Last Updated: | August 13, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endo Pharmaceuticals:
|
Tendonitis Bursitis Pain Shoulder Pain |
Elbow Pain Knee Pain Tendon Injury Muscle, Bone and Cartilage Disorders |
Additional relevant MeSH terms:
|
Bursitis Tendinopathy Joint Diseases Musculoskeletal Diseases Muscular Diseases Tendon Injuries Wounds and Injuries Ketoprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013