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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

Conditions
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Ankle Sprain

Intervention / Treatment
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* Drug: Diclofenac sodium topical gel 1%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female aged 18 years and over. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours. Exclusion criteria: Pain medication was taken within the 6 hours that precede randomization. During the past 3 months: Grade I-III sprain of the same ankle. During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma. Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome). Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac sodium topical gel 1%<br> | Drug: Diclofenac sodium topical gel 1%<br>* Diclofenac sodium topical gel 1%, 4 times daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo, 4 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Movement | Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Movement | 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 | 24 hours and 7 days | 
| Onset of Pain Relief | Onset of perceptible pain relief | Day 1 | 
| Tenderness | 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. | Change from baseline at 24 and 72 hours, 7 days | 
| Ankle Joint Function | 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. | 24 and 72 hours, 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle sprain, soft tissue injury