Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
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|ClinicalTrials.gov Identifier: NCT00757562|
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : March 23, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Desloratadine syrup once daily
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.
Placebo Comparator: Placebo
placebo syrup once daily
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 :
- 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 :
- 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 ]
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