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The Efficacy of Claritin in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01451996
Recruitment Status : Completed
First Posted : October 14, 2011
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

October 10, 2011
October 14, 2011
January 18, 2018
March 13, 2018
March 13, 2018
October 2011
July 2012   (Final data collection date for primary outcome measure)
Change in Wheal Reaction Area From Baseline --- 2 Hour [ Time Frame: 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.
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. ]
Complete list of historical versions of study NCT01451996 on ClinicalTrials.gov Archive Site
Change in Wheal Reaction Area From Baseline --- 1 Hour [ Time Frame: 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.
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 ]
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The Efficacy of Claritin in Healthy Subjects
The Efficacy of Claritin in Healthy Subjects
The primary goal of this study is to examine determinants of the efficacy of Claritin.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Healthy
Drug: Claritin
Subject will be given 10mg Claritin tablet.
  • Claritin ads
    Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.
    Intervention: Drug: Claritin
  • Zyrtec ads
    Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.
    Intervention: Drug: Claritin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
490
December 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01451996
16171A
No
Not Provided
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Anup Malani, J.D., Ph.D University of Chicago
University of Chicago
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP