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CP-481,715 Nickel Allergy Study.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141180
First received: August 30, 2005
Last updated: July 23, 2006
Last verified: November 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Dermatitis, Allergic Contact
 Drug: CP-481,715
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

MedlinePlus related topics: Allergy
Drug Information available for: Nickel
U.S. FDA Resources

Further study details as provided by Pfizer:

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

Estimated Enrollment: 48
Study Start Date: September 2003
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141180     History of Changes
Other Study ID Numbers: A3081018
Study First Received: August 30, 2005
Last Updated: July 23, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Allergic Contact
Skin Diseases
Dermatitis, Contact
 Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013