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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00359138
First received: July 31, 2006
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Hypersensitivity
Drug: desloratadine
Drug: levocetirizine
Drug: Desloratadine placebo tablet
Drug: Levocetirizine placebo capsule
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment [ Time Frame: Starting at Day 8 ] [ Designated as safety issue: No ]
    The number of days after treatment discontinuation until a measurable wheal and flare response.


Enrollment: 36
Study Start Date: February 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00359138     History of Changes
Other Study ID Numbers: P04441
Study First Received: July 31, 2006
Results First Received: May 27, 2010
Last Updated: June 4, 2014
Health Authority: European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Merck Sharp & Dohme Corp.:
Histamine H1 Antagonists
Anti-Allergic Agents

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Histamine H1 Antagonists
Desloratadine
Levocetirizine
Cetirizine
Anti-Allergic Agents
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on July 28, 2014