Ibuprofen 5% Topical Gel CIPT

NCT01771822

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 and/or female subjects (to be confirmed by medical history) 18 years of age or older, female subjects of childbearing potential and males who are using an acceptable form of birth control, subjects who 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 skin disease at the application site, not willing to stop use of systemic or topical
analgesics, corticosteroids, or antihistamines, unwilling or unable 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 Ibuprofen 5% Topical Gel CIPT
Official Title  ICMJE Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers
Brief Summary This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause irritation after repeated topical application to the 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: Ibuprofen 5% topical gel
    0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
  • Drug: Topical gel vehicle
    0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
  • Drug: Sodium lauryl sulfate 0.2%
    0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
  • Drug: Sodium chloride solution 0.9% (saline)
    0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
Study Arms  ICMJE
  • Experimental: Ibuprofen 5% topical gel
    Intervention: Drug: Ibuprofen 5% topical gel
  • Experimental: Topical gel vehicle
    Intervention: Drug: Topical gel vehicle
  • Active Comparator: Sodium lauryl sulfate 0.2%
    Intervention: Drug: Sodium lauryl sulfate 0.2%
  • 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)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2013)
30
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 and/or female subjects (to be confirmed by medical history) 18 years of age or older, female subjects of childbearing potential and males who are using an acceptable form of birth control, subjects who are free of any systemic or dermatologic disorder

Exclusion Criteria:

Have skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, unwilling or unable 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 NCT01771822
Other Study ID Numbers  ICMJE B3491004
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