The Efficacy of Claritin in Healthy Subjects
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Claritin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Anup Malani, J.D., Ph.D, Principal Investigator, Affiliation: University of Chicago
Overall contact:
Marcy deTineo, RN, BSN, Phone: 773.702.5889, Email: mdetineo@surgery.bsd.uchicago.edu
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
Marcy deTineo, RN, BSN, Phone: 773.702.5889, Email: mdetineo@surgery.bsd.uchicago.edu
University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Robert Naclerio, MD, Sub-Investigator
Emir Kamenica, Ph.D, Sub-Investigator
Additional Information
Starting date: October 2011
Last updated: November 4, 2011
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