Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ankle Sprain

In brief

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.

Key facts

Study ID

NCT00640705

Run by

Cerimon Pharmaceuticals

People needed

170

Starts

2008-01-01

Expected to finish

2008-10-01

Last updated by the study team

2008-09-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• PPD — Austin, Texas, United States

Full record on ClinicalTrials.gov

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