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5% Topical Ibuprofen (IBU) for Ankle Sprain

NCT01945034 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2016-05-26

Study results available
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Summary

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.

Conditions

  • Ankle Injuries

Interventions

DRUG

Topical IBU twice daily

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

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

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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01945034 on ClinicalTrials.gov