The Efficacy of Claritin in Healthy Subjects

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Claritin

• Registration Number: NCT01451996
• Lead Sponsor: University of Chicago

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-14
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Results First Submitted: 2018-01-18
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Results First Posted: 2018-03-13
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Wheal Reaction Area From Baseline --- 2 Hour	baseline and 2 hours post administration of Claritin.	A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 2 hours post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm\^2.

Secondary Outcome Measures

Name	Time	Method
Change in Wheal Reaction Area From Baseline --- 1 Hour	baseline and 1 hours post administration of Claritin	A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 1 hour post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm\^2.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States