Status:
COMPLETED
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
Lead Sponsor:
Organon and Co
Conditions:
Chronic Idiopathic Urticaria
Atopy
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
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. Al...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00757562
Start Date
November 1 2002
End Date
October 1 2003
Last Update
August 15 2024
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