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Sponsored by: |
Endo Pharmaceuticals |
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Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00426985 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 330 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | October 2008 |
Primary Completion Date: | May 2008 (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 (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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | EN3269-304 |
Study First Received: | January 24, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00426985 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Tendonitis Bursitis Pain Shoulder Pain |
Elbow Pain Knee Pain Tendon Injury Muscle, Bone and Cartilage Disorders |
Anti-Inflammatory Agents Ketoprofen Tendon Injuries Shoulder Pain Joint Diseases Cyclooxygenase Inhibitors Wounds and Injuries Disorders of Environmental Origin Pain Tendinopathy |
Muscular Diseases Musculoskeletal Diseases Analgesics, Non-Narcotic Cartilage Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Bursitis |
Anti-Inflammatory Agents Ketoprofen Tendon Injuries Molecular Mechanisms of Pharmacological Action Joint Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Wounds and Injuries Disorders of Environmental Origin Enzyme Inhibitors Pharmacologic Actions Tendinopathy |
Muscular Diseases Musculoskeletal Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Bursitis |