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

February 7, 2022 updated by: Organon and Co

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: Levocetirizine placebo capsule
once daily
Drug: Desloratadine placebo tablet
once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Starting at Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

July 31, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04441

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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