Trial Outcomes & Findings for The Efficacy of Claritin in Healthy Subjects (NCT NCT01451996)
NCT ID: NCT01451996
Last Updated: 2018-03-13
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.
COMPLETED
PHASE4
340 participants
baseline and 2 hours post administration of Claritin.
2018-03-13
Participant Flow
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
| 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=99 Participants
|
29.30 years
n=107 Participants
|
27.25 years
n=206 Participants
|
26.40 years
n=157 Participants
|
27.70 years
n=390 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
59 Participants
n=157 Participants
|
212 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
26 Participants
n=157 Participants
|
128 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Black
|
29 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
22 Participants
n=157 Participants
|
110 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Not Black
|
54 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
63 Participants
n=157 Participants
|
230 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
83 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
85 Participants
n=157 Participants
|
340 Participants
n=390 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
| Measure |
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.
|
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.
|
|---|---|---|---|---|
|
Change in Wheal Reaction Area From Baseline --- 2 Hour
|
30.97 Percent change
Standard Error 2.4
|
25.0 Percent change
Standard Error 2.5
|
27.5 Percent change
Standard Error 2.5
|
29.0 Percent change
Standard Error 2.5
|
SECONDARY outcome
Timeframe: baseline and 1 hours post administration of ClaritinA 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
| Measure |
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.
|
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.
|
|---|---|---|---|---|
|
Change in Wheal Reaction Area From Baseline --- 1 Hour
|
14.18 Percent change
Standard Error 3
|
10.83 Percent change
Standard Error 3
|
10.8 Percent change
Standard Error 2
|
17.5 Percent change
Standard Error 2.5
|
Adverse Events
Claritin Ads, Allergy+
Zyrtec Ads, Allergy+
Claritin Ads, Allergy-
Zyrtec Ads, Allergy-
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place