Acute Pain Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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