Atopy Clinical Trial
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
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | October 1, 2003 |
Est. primary completion date | October 1, 2003 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerance | Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36). | ||
Secondary | Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36. | Days 15 and Days 36 |
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