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The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)

Primary Purpose

Hypersensitivity

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
desloratadine
levocetirizine
Desloratadine placebo tablet
Levocetirizine placebo capsule
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity focused on measuring Histamine H1 Antagonists, Anti-Allergic Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must be 18 years of age or older, of either sex. Subjects must have at least a history of positive skin testing to the allergens of tree pollen, grass pollen, house dust mite, or cat dander. Non symptomatic volunteers allergic of different pollen they must be included out of the specific pollinic season. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. Subjects must understand and be able to adhere to visit schedules Subjects must be in general good health. Women of child-bearing potential must have a negative pregnancy test at Day -1 and must use an accepted method of contraception during the entire duration of the study. Exclusion Criteria: Subjects who have persistent asthma. Subjects who have chronic urticaria or atopic dermatosis. Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization, or who must continue to receive treatment as listed below. Medications Prohibited During the Trial and Washout Period Prior to Visit 1 Corticosteroids Intramuscular or intra-articular, 1 month Oral, inhaled, intravenous, rectal, intranasal, or ocular, 7 days High-potency dermatological, 7 days Cromolyn/Lodoxamide/Nedocromil Intranasal, ocular, inhaled, or oral, 2 days Antihistamines Long-acting prescription (eg, levocetirizine, fexofenadine, and desloratadine), 15 days Short-acting (eg, chlorpheniramine, brompheniramine including over-the-counter [OTC] forms, hydroxyzine), 15 days Ocular (eg, levocabastine), 15 days 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 oral, 2 days local, 2 days 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 Subjects with a history of hypersensitivity to desloratadine, to levocetirizine, or any of their excipients. Women who are breast-feeding, pregnant, or intend to become pregnant. Subjects with any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Subjects who have used any investigational drugs within 30 days of randomization. Subjects working between 11 PM and 8 AM (night shift). Subjects who have skin/color pigmentation incompatible with accurate measurements of flare reaction. Subjects with cutaneous hyperactivity: negative prick test control >3 mm. Subjects who are participating in any other clinical study. Subjects who are part of the staff personnel directly involved with this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Desloratadine 5 mg tablet + Levocetirizine placebo capsule

    Desloratadine placebo tablet + Levocetirizine 5 mg capsule

    Desloratadine placebo tablet + Levocetirizine placebo capsule

    Arm Description

    Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

    Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

    Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00359138
    Brief Title
    The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)
    Official Title
    A Double-blind, Double-dummy, Parallel-group, Placebo-controlled, Randomized Study to Assess the Duration of the Suppressive Effects of Desloratadine on the Cutaneous Allergen-induced Wheal and Flare (1) Response After Discontinuation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypersensitivity
    Keywords
    Histamine H1 Antagonists, Anti-Allergic Agents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Desloratadine 5 mg tablet + Levocetirizine placebo capsule
    Arm Type
    Experimental
    Arm Description
    Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
    Arm Title
    Desloratadine placebo tablet + Levocetirizine 5 mg capsule
    Arm Type
    Active Comparator
    Arm Description
    Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
    Arm Title
    Desloratadine placebo tablet + Levocetirizine placebo capsule
    Arm Type
    Placebo Comparator
    Arm Description
    Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
    Intervention Type
    Drug
    Intervention Name(s)
    desloratadine
    Intervention Description
    5 mg tablet once daily
    Intervention Type
    Drug
    Intervention Name(s)
    levocetirizine
    Intervention Description
    5 mg capsule once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Desloratadine placebo tablet
    Intervention Description
    once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Levocetirizine placebo capsule
    Intervention Description
    once daily
    Primary Outcome Measure Information:
    Title
    Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment
    Description
    The number of days after treatment discontinuation until a measurable wheal and flare response.
    Time Frame
    Starting at Day 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must be 18 years of age or older, of either sex. Subjects must have at least a history of positive skin testing to the allergens of tree pollen, grass pollen, house dust mite, or cat dander. Non symptomatic volunteers allergic of different pollen they must be included out of the specific pollinic season. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. Subjects must understand and be able to adhere to visit schedules Subjects must be in general good health. Women of child-bearing potential must have a negative pregnancy test at Day -1 and must use an accepted method of contraception during the entire duration of the study. Exclusion Criteria: Subjects who have persistent asthma. Subjects who have chronic urticaria or atopic dermatosis. Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization, or who must continue to receive treatment as listed below. Medications Prohibited During the Trial and Washout Period Prior to Visit 1 Corticosteroids Intramuscular or intra-articular, 1 month Oral, inhaled, intravenous, rectal, intranasal, or ocular, 7 days High-potency dermatological, 7 days Cromolyn/Lodoxamide/Nedocromil Intranasal, ocular, inhaled, or oral, 2 days Antihistamines Long-acting prescription (eg, levocetirizine, fexofenadine, and desloratadine), 15 days Short-acting (eg, chlorpheniramine, brompheniramine including over-the-counter [OTC] forms, hydroxyzine), 15 days Ocular (eg, levocabastine), 15 days 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 oral, 2 days local, 2 days 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 Subjects with a history of hypersensitivity to desloratadine, to levocetirizine, or any of their excipients. Women who are breast-feeding, pregnant, or intend to become pregnant. Subjects with any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Subjects who have used any investigational drugs within 30 days of randomization. Subjects working between 11 PM and 8 AM (night shift). Subjects who have skin/color pigmentation incompatible with accurate measurements of flare reaction. Subjects with cutaneous hyperactivity: negative prick test control >3 mm. Subjects who are participating in any other clinical study. Subjects who are part of the staff personnel directly involved with this study.

    12. IPD Sharing Statement

    Learn more about this trial

    The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)

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