5% Topical Ibuprofen (IBU) for Ankle Sprain

NCT ID: NCT01945034

Last Updated: 2016-05-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-02-28

Brief Summary

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This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.

Detailed Description

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Conditions

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Ankle Injuries

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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Topical IBU twice daily

Group Type EXPERIMENTAL

Topical IBU twice daily

Intervention Type DRUG

Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days

Placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo twice daily

Intervention Type DRUG

Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days

Topical IBU three times daily

Group Type EXPERIMENTAL

Topical IBU three times daily

Intervention Type DRUG

Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Placebo three times daily

Group Type PLACEBO_COMPARATOR

Placebo three times daily

Intervention Type DRUG

Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Interventions

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Topical IBU twice daily

Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days

Intervention Type DRUG

Placebo twice daily

Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days

Intervention Type DRUG

Topical IBU three times daily

Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Intervention Type DRUG

Placebo three times daily

Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* First or second degree ankle sprain within 48 hours of first dose of study medication
* Medically cleared to participate

Exclusion Criteria

* Similar injury of same joint within last 6 months
* Requires bed rest, surgery, or over-the-counter or prescription analgesics
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Helen Keller Hospital

Sheffield, Alabama, United States

Site Status

Visions Clinical Research - Tucson

Tucson, Arizona, United States

Site Status

Orange County Research Institute

Anaheim, California, United States

Site Status

eStudy Site

San Diego, California, United States

Site Status

San Diego Sports Medicine and Family Health Center

San Diego, California, United States

Site Status

Sunrise Research Institute, Inc.

Miami, Florida, United States

Site Status

L&L Research Choices

Miami, Florida, United States

Site Status

Doctors Research Network

South Miami, Florida, United States

Site Status

Elite Clinical Trials LLLP

Blackfoot, Idaho, United States

Site Status

MedPharmics, LLC

Metairie, Louisiana, United States

Site Status

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Site Status

Heartland Clinical Research, Inc.

Omaha, Nebraska, United States

Site Status

PMG Research of Salisbury

Salisbury, North Carolina, United States

Site Status

Lillestol Research, LLC

Fargo, North Dakota, United States

Site Status

Clinical Trial Network

Houston, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas

San Antonio, Texas, United States

Site Status

Sports Medicine Associates of San Antonio

San Antonio, Texas, United States

Site Status

Danville Orthopedic Clinic

Danville, Virginia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B3491009

Identifier Type: -

Identifier Source: org_study_id

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