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Ibuprofen 5% Topical Gel CIPT

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Carlstadt, New Jersey, 07652 United States
Contact
1-800-718-1021
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

NCT01771822
Pfizer
Completed
Ibuprofen 5% Topical Gel CIPT

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Ibuprofen 5% Topical Gel CIPT
Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Pain
  • 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
  • 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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2013
February 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01771822
B3491004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

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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