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CP-481,715 Nickel Allergy Study.

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ClinicalTrials.gov Identifier: NCT00141180
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : July 25, 2006
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine receptor-1 antagonist.

Condition or disease Intervention/treatment Phase
Dermatitis, Allergic Contact Drug: CP-481,715 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Placebo-Controlled, Randomized, Parallel Group, Multiple-Dose Study to Evaluate the Effects of CP-481,715 on Clinical Response and Cellular Infiltration Following Contact Allergen Challenge to the Skin of Nickel Allergic Subjects.
Study Start Date : September 2003
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Nickel
U.S. FDA Resources




Primary Outcome Measures :
  1. Effect of CP-481,715 on clinical response and cell infiltration after nickel challenge


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A history of nickel allergy confirmed by a visual positive reaction (graded at least ++) to T.R.U.E. TEST.

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding contact allergic dermatitis or untreated, asymptomatic, seasonal allergies at time of dosing).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141180


Locations
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109-0314
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78759
Pfizer Investigational Site
Bryan, Texas, United States, 77802
Denmark
Pfizer Investigational Site
Hellerup, Denmark, 2900
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

ClinicalTrials.gov Identifier: NCT00141180     History of Changes
Other Study ID Numbers: A3081018
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: July 25, 2006
Last Verified: November 2005

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Allergic Contact
Skin Diseases
Dermatitis, Contact
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Nickel
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs