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Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00757562
Collaborator
(none)
97
Enrollment
2
Arms
11
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multiple-Dose Safety and Tolerance Study of Desloratadine in Atopic Pediatric Subjects and Pediatric Subjects With Chronic Idiopathic Urticaria, Ages >=2 to <12 Years, Who Are Poor Metabolizers of Desloratadine
Actual Study Start Date :
Nov 1, 2002
Actual Primary Completion Date :
Oct 1, 2003
Actual Study Completion Date :
Oct 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: DL

Desloratadine syrup once daily

Drug: desloratadine
desloratadine syrup: 1.25 mg (2.5 mL) for subjects >=2 to <6 years, 2.5 mg (5 mL) for subjects >=6 to <12 years, orally once daily in the morning for 36 days.
Other Names:
  • SCH 034117
  • Clarinex

    		•
    Placebo Comparator: Placebo

    placebo syrup once daily

    Drug: Placebo
    placebo syrup: 2.5 mL for subjects >=2 to <6 years, 5 mL for subjects >=6 to <12 years, orally once daily in the morning for 36 days.

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerance [Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36).]

    Secondary Outcome Measures

    1. Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36. [Days 15 and Days 36]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Subjects must:

    • have been previously identified through the previous study P03031 to be atopic or with chronic idiopathic urticaria and be a poor metabolizer of desloratadine.

    • have clinical laboratory tests within normal limits.

    • be in good health, free of any clinically significant disease that could interfere with the study.

    • normal 12-lead ECG

    Exclusion Criteria:
    Subjects who:

    • have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to treatment.

    • have taken any medication that is restricted by the protocol or failed to satisfy washout requirements.

    • are allergic to desloratadine.

    • have used a loratadine- or desloratadine-containing product within the past 30 days.

    • are female and menstruating.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00757562
    Other Study ID Numbers:
    • P02994
    First Posted:
    Sep 23, 2008
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Urticaria
    Chronic Urticaria
    Desloratadine

    Study Results

    No Results Posted as of Feb 17, 2022