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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of 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.

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Detailed Description

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Conditions

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Acute Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Topical gel-4 times daily

Diclofenac sodium topical gel 1%

Group Type EXPERIMENTAL

Diclofenac Sodium

Intervention Type DRUG

Topical gel 1%-4 times daily

Interventions

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Diclofenac Sodium

Topical gel 1%-4 times daily

Intervention Type DRUG

Placebo

Topical gel-4 times daily

Intervention Type OTHER

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No