The Efficacy of Claritin in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Claritin ads; Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.	Drug: Claritin; Subject will be given 10mg Claritin tablet.
Other: Zyrtec ads; Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.	Drug: Claritin; Subject will be given 10mg Claritin tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wheal Reaction Area From Baseline --- 2 Hour	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.	baseline and 2 hours post administration of Claritin.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wheal Reaction Area From Baseline --- 1 Hour	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.	baseline and 1 hours post administration of Claritin

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Anup Malani, J.D., Ph.D, University of Chicago

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 10, 2011
• First Submitted That Met QC Criteria: October 13, 2011
• First Posted (Estimate): October 14, 2011

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: direct-to-consumer advertising
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Loratadine
• Other Study ID Numbers: 16171A