None listed
Conditions
Interventions
Desloratadine 1,25 mg Type of group
Subjects> 2 to
The desloratadine placebo will be administered once a day orally.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:electrocardiogram Measure:Safety and tolerance of LD compared with placebo, based on the results of ECGs performed before and after treatment and adverse experiences. Timepoints:days 15 and 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:physical examination, electrocardiogram, laboratory analysis. Measure:Secondary evaluations will be physical examination, laboratory safety analysis and vital signs. Timepoints:Days 15 and 29 | — |
Countries
Peru, United States
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed