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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00757562
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Merck Sharp & Dohme Corp. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Interventional  (Clinical Trial)
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 : November 1, 2002
Actual Primary Completion Date : October 1, 2003
Actual Study Completion Date : October 1, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
U.S. FDA Resources

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
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.

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00757562     History of Changes
Other Study ID Numbers: P02994
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

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