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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition: Healthy
Intervention: Drug: Claritin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Claritin Ads, Allergy+

Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.

Claritin: Subject will be given 10mg Claritin tablet.

Zyrtec Ads, Allergy+

Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.

Claritin: Subject will be given 10mg Claritin tablet.

Claritin Ads, Allergy-

Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.

Claritin: Subject will be given 10mg Claritin tablet.

Zyrtec Ads, Allergy-

Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.

Claritin: Subject will be given 10mg Claritin tablet.


Participant Flow:   Overall Study
    Claritin Ads, Allergy+   Zyrtec Ads, Allergy+   Claritin Ads, Allergy-   Zyrtec Ads, Allergy-
STARTED   83   87   85   85 
COMPLETED   83   87   85   85 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The sample was stratified into subjects with (Allergy+) and without (Allergy-) a positive skin test and block-randomized each subpopulation to the two advertisement conditions (Claritin ads and Zyrtec ads)

Reporting Groups
  Description
Claritin Ads, Allergy+

Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.

Claritin: Subject will be given 10mg Claritin tablet.

Zyrtec Ads, Allergy+

Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.

Claritin: Subject will be given 10mg Claritin tablet.

Claritin Ads, Allergy-

Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.

Claritin: Subject will be given 10mg Claritin tablet.

Zyrtec Ads, Allergy-

Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.

Claritin: Subject will be given 10mg Claritin tablet.

Total Total of all reporting groups

Baseline Measures
   Claritin Ads, Allergy+   Zyrtec Ads, Allergy+   Claritin Ads, Allergy-   Zyrtec Ads, Allergy-   Total 
Overall Participants Analyzed 
[Units: Participants]
 83   87   85   85   340 
Age 
[Units: Years]
Mean (Full Range)
 27.83 
 (18 to 65) 
 29.30 
 (18 to 65) 
 27.25 
 (18 to 65) 
 26.40 
 (18 to 65) 
 27.70 
 (18 to 65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      43  51.8%      51  58.6%      59  69.4%      59  69.4%      212  62.4% 
Male      40  48.2%      36  41.4%      26  30.6%      26  30.6%      128  37.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
Black   29   35   24   22   110 
Not Black   54   52   61   63   230 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   83   87   85   85   340 


  Outcome Measures

1.  Primary:   Change in Wheal Reaction Area From Baseline --- 2 Hour   [ Time Frame: baseline and 2 hours post administration of Claritin. ]

2.  Secondary:   Change in Wheal Reaction Area From Baseline --- 1 Hour   [ Time Frame: baseline and 1 hours post administration of Claritin ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Anup Malani, J.D., Ph.D
Organization: University of Chicago
phone: 773-702-9602
e-mail: amalani@uchicago.edu



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01451996     History of Changes
Other Study ID Numbers: 16171A
First Submitted: October 10, 2011
First Posted: October 14, 2011
Results First Submitted: January 18, 2018
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018