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

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ClinicalTrials.gov Identifier: NCT00359138
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : November 1, 2010
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypersensitivity Drug: desloratadine Drug: levocetirizine Drug: Desloratadine placebo tablet Drug: Levocetirizine placebo capsule Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Drug: desloratadine
5 mg tablet once daily

Drug: Levocetirizine placebo capsule
once daily
Active Comparator: 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).
 Drug: levocetirizine
5 mg capsule once daily

Drug: Desloratadine placebo tablet
once daily
Placebo Comparator: 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).
 Drug: Desloratadine placebo tablet
once daily

Drug: Levocetirizine placebo capsule
once daily


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment [ Time Frame: Starting at Day 8 ]
    The number of days after treatment discontinuation until a measurable wheal and flare response.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00359138    
Other Study ID Numbers: P04441
First Posted: August 1, 2006    Key Record Dates
Results First Posted: November 1, 2010
Last Update Posted: June 26, 2015
Last Verified: May 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Histamine H1 Antagonists
Anti-Allergic Agents
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Immune System Diseases
Cetirizine
Loratadine
Levocetirizine
Desloratadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Cholinergic Antagonists
Cholinergic Agents
Antipruritics
Dermatologic Agents