The Efficacy of Claritin in Healthy Subjects

NCT ID: NCT01451996

Last Updated: 2018-03-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Claritin ads

Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.

Group Type OTHER

Claritin

Intervention Type DRUG

Subject will be given 10mg Claritin tablet.

Zyrtec ads

Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.

Group Type OTHER

Claritin

Intervention Type DRUG

Subject will be given 10mg Claritin tablet.

Interventions

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Claritin

Subject will be given 10mg Claritin tablet.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anup Malani, J.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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16171A

Identifier Type: -

Identifier Source: org_study_id

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