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This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class > 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens. Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily, or placebo once daily for 8 days of treatment followed by 11 days of skin testing after discontinuation of the antihistamine treatment phase. The duration of the suppressive effects of desloratadine on cutaneous allergen-induced wheal and flare responses after discontinuation of a one-week treatment will be established.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desloratadine 5 mg tablet + Levocetirizine placebo capsule | Experimental | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
|
| Desloratadine placebo tablet + Levocetirizine 5 mg capsule | Active Comparator | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
|
| Desloratadine placebo tablet + Levocetirizine placebo capsule | Placebo Comparator | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desloratadine | Drug | 5 mg tablet once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment | The number of days after treatment discontinuation until a measurable wheal and flare response. | Starting at Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
Medications Prohibited During the Trial and Washout Period Prior to Visit 1
Corticosteroids
Cromolyn/Lodoxamide/Nedocromil
Antihistamines
Leukotriene inhibitors (eg, montelukast), 7 days
Systemic antibiotics, 14 days (the washout refers to antibiotics used to treat an upper or lower respiratory tract infection)
Immunotherapy (desensitization), 1 year
Decongestants
Ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs; eg, Toradol), 5 days
Investigational medications, 30 days
Tricyclic antidepressants (eg, amitriptyline, clomipramine, doxepin, imipramine, trimipramine, amoxapine, desipramine, nortriptyline, protriptyline), 30 days
Tetracyclic antidepressants (eg, maprotiline, mirtazapine), 30 days
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| ID | Title | Description |
|---|---|---|
| FG000 | Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
| FG001 | Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
| FG002 | Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
| BG001 | Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule |
| 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 | Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment | The number of days after treatment discontinuation until a measurable wheal and flare response. | Posted | Mean | Standard Error | Days | Starting at Day 8 |
|
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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 | Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
| C472067 | levocetirizine |
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| levocetirizine |
| Drug |
5 mg capsule once daily |
|
| Desloratadine placebo tablet | Drug | once daily |
|
| Levocetirizine placebo capsule | Drug | once daily |
|
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
| BG002 | Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule |
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). | 0 | 12 | 4 | 12 |
| EG002 | Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). | 0 | 12 | 1 | 12 |
| Dry Mouth | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Muscle Contracture | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
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