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

NCT00757562 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2024-08-15

No results posted yet for this study

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.

Conditions

  • Chronic Idiopathic Urticaria
  • Atopy

Interventions

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.

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.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-01
Primary Completion
2003-10-01
Completion
2003-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00757562 on ClinicalTrials.gov