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

NCT ID: NCT01255423

Last Updated: 2012-10-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-06-30

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.

Detailed Description

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Conditions

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Ankle Sprain

Keywords

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Ankle sprain, soft tissue injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diclofenac sodium topical gel 1%

Group Type EXPERIMENTAL

Diclofenac sodium topical gel 1%

Intervention Type DRUG

Diclofenac sodium topical gel 1%, 4 times daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, 4 times daily

Interventions

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Diclofenac sodium topical gel 1%

Diclofenac sodium topical gel 1%, 4 times daily

Intervention Type DRUG

Placebo

Placebo, 4 times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female aged 18 years and over.
2. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
3. Injury within past 12 hours.

Exclusion Criteria

1. Pain medication was taken within the 6 hours that precede randomization.
2. During the past 3 months: Grade I-III sprain of the same ankle.
3. 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.
4. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
5. 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

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Novartis

Locations

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Birmingham, Alabama, United States

Site Status

Aventura, Florida, United States

Site Status

Hialeah, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Berlin, New Jersey, United States

Site Status

Columbia, South Carolina, United States

Site Status

El Paso, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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197-P-320

Identifier Type: -

Identifier Source: org_study_id