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NCT01945034 Clinical Trial

5% Topical Ibuprofen (IBU) for Ankle Sprain

Ankle Injuries Clinical Trial

Official title:
Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01945034
Other study ID # B3491009
Secondary ID
Status Completed
Phase Phase 3
First received June 21, 2013
Last updated March 26, 2015
Start date November 2013
Est. completion date February 2015

Study information
Verified date March 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 305
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Orange County Research Institute Anaheim California
United States Elite Clinical Trials LLLP Blackfoot Idaho
United States Danville Orthopedic Clinic Danville Virginia
United States Lillestol Research, LLC Fargo North Dakota
United States Clinical Trial Network Houston Texas
United States eStudySite, La Mesa La Mesa California
United States MedPharmics, LLC Metairie Louisiana
United States L&L Research Choices Miami Florida
United States Sunrise Research Institute, Inc. Miami Florida
United States eStudySite, Inc. Oceanside California
United States Heartland Clinical Research, Inc. Omaha Nebraska
United States Quality Clinical Research, Inc. Omaha Nebraska
United States PMG Research of Salisbury Salisbury North Carolina
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Sports Medicine Associates of San Antonio San Antonio Texas
United States San Diego Sports Medicine and Family Health Center San Diego California
United States Helen Keller Hospital Sheffield Alabama
United States Doctors Research Network South Miami Florida
United States Visions Clinical Research - Tucson Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sum of pain intensity difference on weight bearing over 24 hours after first dose 24 hours No
Primary Sum of pain intensity difference on weight bearing over 3 days 3 days No
Secondary Sum of pain intensity difference at rest over 24 hours 24 hours No
Secondary Subject Global Assessment of Ankle Injury Days 3 and 10 No
Secondary Physician Global Assessment of Ankle Injury Days 3 and 10 No
Secondary Ankle Pain at Rest Each post-dose time point through 7 days No
Secondary Ankle Pain Upon Weight Bearing Each post-dose timepoing through 7 days No
Secondary Time weighted sum of pain intensity difference at rest Over 6 hours on Day 1 and over 2 hours on Day 3 No
Secondary Time weighted sum of pain intensity difference upon weight bearing Over 6 hours on Day 1 and over 2 hours on Day 3 No
Secondary Time weighted pain intensity difference score Over each day, over 3 days, over 7 days No
Secondary Subject assessment of normal function and activity Days 3 and 10 No
Secondary Subject Global Assessment of Medication Day 10 No
Secondary Time to onset of first perceptible relief First 6 hours after Dose 1 No
Secondary Time to onset of meaningful relief First 6 hours after Dose 1 No
Secondary Time to rescue medication after initial dose, and after each subsequent dose provided that at least 25% of subjects take rescue medication 10 days No
Secondary Number of doses of rescue medication used First 7 days of dosing No
Secondary Percentage of subjects taking rescue medication 10 days No
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