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Trial record 1 of 1 for:    NCT01771822
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Ibuprofen 5% Topical Gel CIPT

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ClinicalTrials.gov Identifier: NCT01771822
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 5, 2012
First Posted Date  ICMJE January 18, 2013
Last Update Posted Date February 28, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2013)
Assessment of local skin irritation at patch sites [ Time Frame: Daily for 21 days, Days 2 through 22 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01771822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2013)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Days 1 through 22, + 28 days after last product administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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