Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients 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

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

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The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).

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Detailed Description

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Conditions

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Grade I/II Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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diclofenac diethylamine gel 2.32% gel twice a day

drug

Group Type EXPERIMENTAL

diclofenac diethylamine gel 2.32%

Intervention Type DRUG

diclofenac diethylamine gel 2.32% twice a day

diclofenac diethylamine gel 2.32% gel three times a day

drug

Group Type EXPERIMENTAL

diclofenac diethylamine gel 2.32%

Intervention Type DRUG

diclofenac diethylamine gel 2.32% three times a day

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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diclofenac diethylamine gel 2.32%

diclofenac diethylamine gel 2.32% twice a day

Intervention Type DRUG

diclofenac diethylamine gel 2.32%

diclofenac diethylamine gel 2.32% three times a day

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Acute sprain of the lateral ankle, Grade I-II .

Exclusion Criteria

1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
2. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No