Trial Outcomes & Findings for The Efficacy of Claritin in Healthy Subjects (NCT NCT01451996)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

340 participants

Primary outcome timeframe

baseline and 2 hours post administration of Claritin.

Results posted on

2018-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	83	87	85	85
Overall Study COMPLETED	83	87	85	85
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Efficacy of Claritin in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Claritin Ads, Allergy+ n=83 Participants 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+ n=87 Participants 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- n=85 Participants 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- n=85 Participants 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 n=340 Participants Total of all reporting groups
Age, Continuous	27.83 years n=5 Participants	29.30 years n=7 Participants	27.25 years n=5 Participants	26.40 years n=4 Participants	27.70 years n=21 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	51 Participants n=7 Participants	59 Participants n=5 Participants	59 Participants n=4 Participants	212 Participants n=21 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	36 Participants n=7 Participants	26 Participants n=5 Participants	26 Participants n=4 Participants	128 Participants n=21 Participants
Race/Ethnicity, Customized Black	29 Participants n=5 Participants	35 Participants n=7 Participants	24 Participants n=5 Participants	22 Participants n=4 Participants	110 Participants n=21 Participants
Race/Ethnicity, Customized Not Black	54 Participants n=5 Participants	52 Participants n=7 Participants	61 Participants n=5 Participants	63 Participants n=4 Participants	230 Participants n=21 Participants
Region of Enrollment United States	83 Participants n=5 Participants	87 Participants n=7 Participants	85 Participants n=5 Participants	85 Participants n=4 Participants	340 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Claritin Ads, Allergy+ n=83 Participants 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+ n=87 Participants 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- n=85 Participants 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- n=85 Participants 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.
Change in Wheal Reaction Area From Baseline --- 2 Hour	27.5 Percent change Standard Error 2.5	29.0 Percent change Standard Error 2.5	30.97 Percent change Standard Error 2.4	25.0 Percent change Standard Error 2.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Claritin Ads, Allergy+ n=83 Participants 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+ n=87 Participants 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- n=85 Participants 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- n=85 Participants 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.
Change in Wheal Reaction Area From Baseline --- 1 Hour	10.8 Percent change Standard Error 2	17.5 Percent change Standard Error 2.5	14.18 Percent change Standard Error 3	10.83 Percent change Standard Error 3

Adverse Events

Claritin Ads, Allergy+

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Zyrtec Ads, Allergy+

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Claritin Ads, Allergy-

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Zyrtec Ads, Allergy-

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anup Malani, J.D., Ph.D

University of Chicago

Phone: 773-702-9602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place