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CP-481,715 Nickel Allergy Study.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141180
First Posted: September 1, 2005
Last Update Posted: July 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
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.

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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).
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00141180     History of Changes
Other Study ID Numbers: A3081018
First Submitted: August 30, 2005
First Posted: September 1, 2005
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