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.
Overview
- Phase
- Phase 2
- Intervention
- diclofenac sodium
- Conditions
- Ankle Sprain
- Sponsor
- Cerimon Pharmaceuticals
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
A
Topical diclofenac sodium patch
Intervention: diclofenac sodium
B
Topical patch identical in appearance to active comparator, except without diclofenac sodium
Intervention: Matching placebo patch
Outcomes
Primary Outcomes
Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.
Time Frame: 7 days
Secondary Outcomes
- Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain.(7 days)