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| Sponsors and Collaborators: |
Cerimon Pharmaceuticals PPD |
|---|---|
| Information provided by: | Cerimon Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00869180 |
Purpose
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Pain Ankle Sprain |
Drug: Diclofenac Sodium Drug: Matching Placebo Patch |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 Acute Pain Due to Mild to Moderate Ankle Sprain |
| Estimated Enrollment: | 208 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Diclofenac Sodium Patch: Experimental |
Drug: Diclofenac Sodium
Topical diclofenac patch applied once daily to area of pain
|
| Topical Placebo Patch: Placebo Comparator |
Drug: Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
|
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains.
Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice 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.
Eligibility| Ages Eligible for Study: | 17 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shaily J Reichert | 650-827-4032 | sreichert@cerimon.com |
| Contact: Jane Kim | 650-827-4084 | jkim@cerimon.com |
| United States, Texas | |
| PPD | Recruiting |
| Austin, Texas, United States, 78704 | |
More Information
| Responsible Party: | Cerimon Pharmaceuticals ( Shaily J. Reichert, V.P. of Clinical Development ) |
| Study ID Numbers: | DCF-004 |
| Study First Received: | March 24, 2009 |
| Last Updated: | March 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00869180 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
diclofenac ankle sprain acute pain |
topical patch Acute Pain due to Mild to Moderate Ankle Sprain |
|
Anti-Inflammatory Agents Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Wounds and Injuries Diclofenac Disorders of Environmental Origin |
Anti-Inflammatory Agents, Non-Steroidal Pain Peripheral Nervous System Agents Analgesics Antirheumatic Agents Sprains and Strains |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Wounds and Injuries Disorders of Environmental Origin Diclofenac Enzyme Inhibitors Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Sprains and Strains |
