Back to resultsSafety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
Primary Purpose
Chronic Idiopathic Urticaria, Atopy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
desloratadine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Urticaria
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DL
Placebo
Arm Description
Desloratadine syrup once daily
placebo syrup once daily
Outcomes
Primary Outcome Measures
Safety and Tolerance
Secondary Outcome Measures
Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00757562
Brief Title
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2002 (Actual)
Primary Completion Date
October 1, 2003 (Actual)
Study Completion Date
October 1, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria, Atopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DL
Arm Type
Experimental
Arm Description
Desloratadine syrup once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo syrup once daily
Intervention Type
Drug
Intervention Name(s)
desloratadine
Other Intervention Name(s)
SCH 034117, Clarinex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
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