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

July 31, 2006
June 4, 2014
February 2006
May 2006   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00359138 on ClinicalTrials.gov Archive Site
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The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypersensitivity
  • Drug: desloratadine
    5 mg tablet once daily
  • Drug: levocetirizine
    5 mg capsule once daily
  • Drug: Desloratadine placebo tablet
    once daily
  • Drug: Levocetirizine placebo capsule
    once daily
  • 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).
    Interventions:
    • Drug: desloratadine
    • Drug: Levocetirizine placebo capsule
  • 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).
    Interventions:
    • Drug: levocetirizine
    • Drug: Desloratadine placebo tablet
  • 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).
    Interventions:
    • Drug: Desloratadine placebo tablet
    • Drug: Levocetirizine placebo capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00359138
P04441
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP