Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

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 blunt soft tissue injuries/contusions of the limbs

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Detailed Description

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Conditions

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Acute Blunt Soft Tissue Injuries/Contusions

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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Diclofenac sodium topical gel 1%

Group Type EXPERIMENTAL

Diclofenac sodium

Intervention Type DRUG

Topical gel 1%- 4 times daily

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Topical gel - 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.
* Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.Anticipated time between injury and treatment must be less than 3 hours.

Exclusion Criteria

* Pain medication was taken within the 6 hours that precede randomization.Any physical impairment that would influence the study's efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No