The Efficacy of Claritin in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01451996
First received: October 10, 2011
Last updated: December 9, 2013
Last verified: December 2013

October 10, 2011
December 9, 2013
October 2011
July 2012   (final data collection date for primary outcome measure)
The difference in wheal area following the baseline and time 2:00 challenges [ Time Frame: Wheal area is assessed at baseline and 2 hours post administration of Claritin. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01451996 on ClinicalTrials.gov Archive Site
The difference in wheal area following the baseline and time 1:00 challenges [ Time Frame: Wheal area is assessed at baseline and 1 hours post administration of Claritin ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Efficacy of Claritin in Healthy Subjects
The Efficacy of Claritin in Healthy Subjects

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

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Healthy
Drug: Claritin
Subject will be given 10mg Claritin tablet.
Claritin
Subject will be given 10mg Claritin tablet.
Intervention: Drug: Claritin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
490
December 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01451996
16171A
No
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Anup Malani, J.D., Ph.D University of Chicago
University of Chicago
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP