The Efficacy of Claritin in Healthy Subjects

NCT01451996 | Completed Phase 4 Results

• 1 other identifier: 16171A
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

direct-to-consumer advertising

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Wheal Reaction Area From Baseline --- 1 Hour

  baseline and 1 hours post administration of Claritin

Study Arms (2)

Claritin ads

OTHER

Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.

Drug: Claritin

Zyrtec ads

OTHER

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

Drug: Claritin

Interventions

Claritin DRUG

Subject will be given 10mg Claritin tablet.

Claritin ads; Zyrtec ads

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Males and females between 18 and 65 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Loratadine

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Anup Malani, J.D., Ph.D
• Organization: University of Chicago

amalani@uchicago.edu

773-702-9602

Study Officials

• Anup Malani, J.D., Ph.D

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 14, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-03

Locations

US (1)