Status:
TERMINATED
Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
Lead Sponsor:
Cerimon Pharmaceuticals
Collaborating Sponsors:
PPD Development, LP
Conditions:
Ankle Sprain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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 stu...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00640705
Start Date
January 1 2008
End Date
October 1 2008
Last Update
September 4 2008
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78744