Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

Study Overview
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Brief Summary
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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 either the left or right ankle. The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.

Detailed Description
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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.

Official Title
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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 Ankle Sprain.

Conditions
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Ankle Sprain

Intervention / Treatment
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* Drug: diclofenac sodium
* Drug: Matching placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 75 years of age Has sustained a painful Grade 1 or 2 ankle sprain (Appendix H) no more than 48 hours prior to study entry Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS) Exclusion Criteria: Grade 3 ankle sprain or bilateral sprain (see Appendix H) Previous injury to the same ankle within 3 months prior to current injury Aspirin or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (Appendix B) Opioid use within 24 hours prior to study entry Topical treatment, other than ice packs, applied to the painful region since time of injury A history of peptic ulcer disease within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder A history of, or evidence for, underlying disease in the injured ankle, such as osteoarthritis or gout Clinically significant, poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease A history of hypersensitivity to diclofenac or diclofenac-containing products A history of intolerance to acetaminophen (rescue medication in this trial) A history of skin sensitivity to adhesives (e.g. adhesive tape) Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Topical diclofenac sodium patch | Drug: diclofenac sodium<br>* 15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily<br>* Other names: diclofenac;|
| Placebo Comparator: B<br>Topical patch identical in appearance to active comparator, except without diclofenac sodium | Drug: Matching placebo patch<br>* Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily<br>* Other names: placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain. |  | 7 days |