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The Efficacy of Claritin in Healthy Subjects

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Claritin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Anup Malani, J.D., Ph.D, Principal Investigator, Affiliation: University of Chicago

Summary

The primary goal of this study is to examine determinants of the efficacy of Claritin.

Clinical Details

Official title: The Efficacy of Claritin in Healthy Subjects

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)

Primary outcome: The difference in wheal area following the baseline and time 2:00 challenges

Secondary outcome: The difference in wheal area following the baseline and time 1:00 challenges

Detailed description: Subjects will be given Claritin 10mg tablet. Subjects will be challenged with histamine via skin prick prior to Claritin administration and at 1 and 2 hours post administration. We will measure and record wheal and flare area 10 minutes following each challenge.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria. 1. Males and females between 18 and 65 years of age. Exclusion Criteria. 1. Pregnant or lactating women. 2. Upper respiratory infection within 14 days of study start. 3. Women of childbearing potential not using specific contraception method(s) (i. e., birth control pills, depo Provera, double barrier) as well as women who are breastfeeding. 4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease). 5. Use of any other investigational agent in the last 30 days. 6. Use of medications that may affect skin testing. Specifically, subjects are excluded if they have used an antihistamine during the 4 days preceding their treatment visit.

Locations and Contacts

University of Chicago, Chicago, Illinois 60637, United States
Additional Information

Starting date: October 2011
Last updated: December 9, 2013

Page last updated: August 20, 2015

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