Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Ankle Injuries
Sex
Females and Males
Age
12 + years
Inclusion Criteria
Show details
- First or second degree ankle sprain within 48 hours of first dose of study medication
- Medically cleared to participate
Exclusion Criteria
Show details
- Similar injury of same joint within last 6 months
- Requires bed rest, surgery, or over-the-counter or prescription analgesics
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Ankle Injuries5% Topical Ibuprofen (IBU) for Ankle Sprain
NCT01945034
- Sheffield, Alabama
- Tucson, Arizona
- Anaheim, California
- San Diego, California
- San Diego, California
- Miami, Florida
- Miami, Florida
- S. Miami, Florida
- Blackfoot, Idaho
- Metairie, Louisiana
- Omaha, Nebraska
- Omaha, Nebraska
- Salisbury, North Carolina
- Fargo, North Dakota
- Houston, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- Danville, Virginia
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | 5% Topical Ibuprofen (IBU) for Ankle Sprain | |||
Official Title ICMJE | Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Ankle Injuries | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 304 | |||
Original Estimated Enrollment ICMJE | 340 | |||
Actual Study Completion Date ICMJE | February 2015 | |||
Actual Primary Completion Date | February 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01945034 | |||
Other Study ID Numbers ICMJE | B3491009 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |