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 Soft Tissue Injuries
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the painful area.
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in
patients with mild to moderate soft tissue injuries.
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
14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a
follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary
in which assessments including pain intensity and pain relief will be recorded twice daily.
Functional disability and global impression of change will be recorded in the diary at study
visits, 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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