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Sponsors and Collaborators: |
Cerimon Pharmaceuticals PPD |
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Information provided by: | Cerimon Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00640939 |
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist.
The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.
Condition | Intervention | Phase |
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Rotator Cuff Tendonitis Bicipital Tendonitis Subdeltoid Bursitis of the Shoulder Subacromial Bursitis of the Shoulder Medial Epicondylitis of the Elbow Lateral Epicondylitis of the Elbow DeQuervain's Tenosynovitis of the Wrist |
Drug: diclofenac sodium Drug: Matching Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Pain Due to Mild to Moderate Tendonitis or Bursitis |
Enrollment: | 308 |
Study Start Date: | December 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Topical diclofenac sodium patch
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Drug: diclofenac sodium
15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
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B: Placebo Comparator
Topical patch identical in appearance to active comparator
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Drug: Matching Placebo
Matching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
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Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cerimon Pharmaceuticals, Inc. ( Dan Levitt, MD ) |
Study ID Numbers: | DCF-003 |
Study First Received: | March 18, 2008 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00640939 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Tendonitis Bursitis |
Anti-Inflammatory Agents Tendon Injuries Tennis Elbow Joint Diseases Cyclooxygenase Inhibitors Wounds and Injuries Disorders of Environmental Origin Diclofenac Pain Arm Injuries |
Tendinopathy Muscular Diseases Musculoskeletal Diseases Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Tenosynovitis Bursitis |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Disorders of Environmental Origin Arm Injuries Tendinopathy Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Tendon Injuries Tennis Elbow |
Joint Diseases Cyclooxygenase Inhibitors Wounds and Injuries Diclofenac Enzyme Inhibitors Pharmacologic Actions Muscular Diseases Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Tenosynovitis Bursitis |