STUDY ON THE SAFETY AND TOLERANCE OF MULTIPLE DOSE OF DESLORATADINE IN PEDIATRIC SUBJECTS ATOPICOS AND PEDIATRIC SUBJECTS WITH CIU, FROM> 2 TO <12 YEARS OF AGE, WHICH ARE SLOW METABOLIZERS OF DYSORATADINE
Not Applicable
- Registration Number
- PER-078-02
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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
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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method