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Completed

NCT Number: NCT00757562

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

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.

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Key information

Conditions

Chronic Idiopathic Urticaria Atopy Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

desloratadine

Drug

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

Drug

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.

Primary outcomes

  1. Safety and Tolerance

    Time frame: Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36).

Secondary outcomes

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

    Time frame: Days 15 and Days 36

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Sep 23, 2008
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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