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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00757562
First received: September 22, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Idiopathic Urticaria
Atopy
 Drug: desloratadine
Drug: Placebo
 Phase 3

Schering-Plough has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hives
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Safety and Tolerance [ Time Frame: Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 97
Study Start Date: November 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00757562     History of Changes
Other Study ID Numbers: P02994
Study First Received: September 22, 2008
Last Updated: September 22, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Loratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Antipruritics
Dermatologic Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 22, 2013