Text Size

The Efficacy of Claritin in Healthy Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anup Malani, University of Chicago
ClinicalTrials.gov Identifier:
NCT01451996
First received: October 10, 2011
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Drug: Claritin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Official Title: The Efficacy of Claritin in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Loratadine
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 490
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Claritin
Subject will be given 10mg Claritin tablet.
 Drug: Claritin
Subject will be given 10mg Claritin tablet.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451996

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Anup Malani, J.D., Ph.D University of Chicago
  More Information

No publications provided

Responsible Party: Anup Malani, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01451996     History of Changes
Other Study ID Numbers: 16171A
Study First Received: October 10, 2011
Last Updated: August 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
direct-to-consumer advertising

Additional relevant MeSH terms:
Loratadine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
 Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013