RIPT of Ibuprofen Topical Gel

NCT01787448

Last updated date
Study Location
Pfizer Investigational Site
Carlstadt, New Jersey, 07652, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder

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


Have any visible skin disease at the application site, not willing to stop use of systemic
or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of
sunscreens, creams, or similar products on the back during the study

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Advanced Information
Descriptive Information
Brief Title  ICMJE RIPT of Ibuprofen Topical Gel
Official Title  ICMJE Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers
Brief Summary This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Topical gel vehicle
    0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
  • Drug: Sodium lauryl sulfate 0.1%
    0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
  • Drug: Sodium chloride solution 0.9% (saline)
    0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
Study Arms  ICMJE
  • Experimental: Ibuprofen 5% topical gel
    Intervention: Drug: Topical gel vehicle
  • Experimental: Topical gel vehicle
    Intervention: Drug: Topical gel vehicle
  • Active Comparator: Sodium lauryl sulfate 0.1%
    Intervention: Drug: Sodium lauryl sulfate 0.1%
  • Sham Comparator: Sodium chloride solution 0.9% (saline)
    Intervention: Drug: Sodium chloride solution 0.9% (saline)
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: February 27, 2013)
234
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
200
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder

Exclusion Criteria:

Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01787448
Other Study ID Numbers  ICMJE B3491007
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP