The Efficacy of Claritin in Healthy Subjects

Study Overview
=================
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.

Official Title
-----------------
The Efficacy of Claritin in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Claritin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria. 1. Males and females between 18 and 65 years of age. Exclusion Criteria. Pregnant or lactating women. Upper respiratory infection within 14 days of study start. 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. 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). Use of any other investigational agent in the last 30 days. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
direct-to-consumer advertising