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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

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Claritin Phase 4

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  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Efficacy of Claritin in Healthy Subjects
Study Start Date : October 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Loratadine
U.S. FDA Resources

Arm Intervention/treatment
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.
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451996


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Anup Malani, J.D., Ph.D University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01451996     History of Changes
Other Study ID Numbers: 16171A
First Posted: October 14, 2011    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by University of Chicago:
direct-to-consumer advertising

Additional relevant MeSH terms:
Loratadine
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs