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The primary goal of this study is to examine determinants of the efficacy of Claritin.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Claritin ads | Other | Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin. |
|
| Zyrtec ads | Other | Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Claritin | Drug | Subject will be given 10mg Claritin tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wheal Reaction Area From Baseline --- 1 Hour | 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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Inclusion Criteria.
1. Males and females between 18 and 65 years of age.
Exclusion Criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Anup Malani, J.D., Ph.D | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Percent change | baseline and 2 hours post administration of Claritin. |
|
2 hours post Claritin use
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anup Malani, J.D., Ph.D | University of Chicago | 773-702-9602 | amalani@uchicago.edu |
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| ID | Term |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| baseline and 1 hours post administration of Claritin |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | Change in Wheal Reaction Area From Baseline --- 1 Hour | 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. | Posted | Mean | Standard Error | Percent change | baseline and 1 hours post administration of Claritin |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | 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. | 0 | 87 | 0 | 87 |
| EG002 | 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. | 0 | 85 | 0 | 85 |
| EG003 | 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. | 0 | 85 | 0 | 85 |
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| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |