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5% Topical Ibuprofen (IBU) for Ankle Sprain

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NCT01945034

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Helen Keller Hospital
Sheffield, Alabama, 35660 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankle Injuries
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- First or second degree ankle sprain within 48 hours of first dose of study medication

- Medically cleared to participate

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Similar injury of same joint within last 6 months

- Requires bed rest, surgery, or over-the-counter or prescription analgesics

NCT01945034
Pfizer
Completed
5% Topical Ibuprofen (IBU) for Ankle Sprain

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5% Topical Ibuprofen (IBU) for Ankle Sprain
Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ankle Injuries
  • 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
  • Experimental: Topical IBU twice daily
    Intervention: Drug: Topical IBU twice daily
  • Placebo Comparator: Placebo twice daily
    Intervention: Drug: Placebo twice daily
  • Experimental: Topical IBU three times daily
    Intervention: Drug: Topical IBU three times daily
  • Placebo Comparator: Placebo three times daily
    Intervention: Drug: Placebo three times daily
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
February 2015
February 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01945034
B3491009
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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