NCT00640705

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

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.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Cerimon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Sprain

Interventions

Type	Name	Description
DRUG	diclofenac sodium	15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
DRUG	Matching placebo patch	Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-07-01
• Completion: 2008-10-01
• First posted: 2008-03-21
• Last updated: 2008-09-04

Locations

1 site across 1 country: United States