CP-481,715 Nickel Allergy Study.

Dermatitis, Allergic Contact Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141180
• Other study ID #: A3081018
• Status: Completed
• Phase: Phase 1
• First received: August 30, 2005
• Last updated: July 23, 2006
• Start date: September 2003
• Est. completion date: October 2005

Study information

• Verified date: November 2005
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis, Allergic Contact

Intervention

Drug:
• CP-481,715

Locations

Country	Name	City	State
Denmark	Pfizer Investigational Site	Hellerup
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Bryan	Texas
United States	Pfizer Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of CP-481,715 on clinical response and cell infiltration after nickel challenge