Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

Phase 3

Completed

• Conditions: Ankle Sprain
• Interventions: Drug: Diclofenac sodium topical gel 1%; Drug: Placebo

• Registration Number: NCT01255423
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-06-08
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-03
• Last Update Submitted: 2012-09-03
• Results First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac sodium topical gel 1%	Diclofenac sodium topical gel 1%	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain on Movement	72 hours	Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"

Secondary Outcome Measures

Name	Time	Method
Pain on Movement	24 hours and 7 days	Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"
Onset of Pain Relief	Day 1	Onset of perceptible pain relief
Tenderness	Change from baseline at 24 and 72 hours, 7 days	Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.
Ankle Joint Function	24 and 72 hours, 7 days	Ankle joint function score (Karlsson Scoring scale which ranges from 0 "worst possible score" to 90 "best possible score")at 24 and 72 hours and 7 days.