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5% Topical Ibuprofen (IBU) for Ankle Sprain

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NCT01945034

Last updated on November 17, 2019
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Study Location
Helen Keller Hospital
Sheffield, Alabama, 35660 United States
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Contact
1-800-718-1021
[email protected]
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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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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 SummaryThis 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 DescriptionNot 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
  • 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
Study Arms  ICMJE
  • 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
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
 (submitted: April 19, 2016)		304
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)		340
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion DateFebruary 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2016

ICMJE     Data element required by the

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

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