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| Sponsor: | Cerimon Pharmaceuticals |
|---|---|
| Collaborator: |
PPD |
| Information provided by: | Cerimon Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00640939 |
Purpose
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 |
|---|---|---|
|
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: A
Topical diclofenac sodium patch
|
Drug: diclofenac sodium
15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
Other Name: diclofenac
|
|
Placebo Comparator: B
Topical patch identical in appearance to active comparator
|
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
Other Name: placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Dan Levitt, MD, Cerimon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00640939 History of Changes |
| Other Study ID Numbers: | DCF-003 |
| Study First Received: | March 18, 2008 |
| Last Updated: | August 5, 2008 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Tendonitis Bursitis |
|
Bursitis Tennis Elbow Tendinopathy Tenosynovitis Joint Diseases Musculoskeletal Diseases Arm Injuries Wounds and Injuries Muscular Diseases Tendon Injuries Diclofenac 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 |