DOUBLE-BLIND, RANDOMIZED, MULTICENTER, PARALLEL GROUPS AND CONTROLLED WITH PLACEBO STUDY, OF 15 DAYS OF DURATION, ON THE SAFETY OF THE DISLORATADINE SYRUP IN CHILDREN OVER 6 MONTHS AND LESS THAN 2 YEARS OF AGE
- Conditions
- -T784 Allergy, unspecifiedAllergy, unspecifiedT784
- Registration Number
- PER-045-01
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Children must be> 6 months to <2 years old, and can be of both sexes and any race.
• Children should require treatment with antihistamines or have received some treatment with antihistamines in the past.
• Children must have a good general health, which will be confirmed by routine clinical examinations (medical history, physical examination and electrocardiogram).
• Children should not suffer from any clinically significant disease that may interfere with the study evaluations.
• Parents / guardians must agree to give written informed consent and be able to comply with the administration of doses and visit schedules. Likewise, children must meet the requirements of the study.
• Children who have a history of allergies to more than two classes of medications, or who are allergic to antihistamines or can not tolerate them
• Children who have had a sinus or upper respiratory tract infection that required the administration of antibiotic treatment within 14 days prior to Screening or have had a viral infection of the upper respiratory tract within 7 days days before the selection
• Children who have used a drug in Research within 30 days prior to the Selection.
• Children with a history of hypersensitivity to the study drugs or their excipients.
• Children who are relatives of someone who intervenes directly with the study in the research center.
• Children who have been randomized in this study before.
• Children who currently have evidence of an autoimmune, psychiatric, neurological, renal, hepatic, cardiovascular or hematopoietic disease, or who have evidence of some other disease that prevents their participation in the study. Special attention should be paid to children with conditions that could interfere with the absorption, distribution, metabolism, or excretion of study medication at present.
• Children with a history of noncompliance with treatment protocols or medication administration.
• Children whose parents / guardians can not complete the diaries reliably.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Frequency tabulations will be provided by treatment group (DL 1 mg, DL 1.25 mg, and placebo). Adverse events will also be tabulated by age, stratum, gender and race.<br>Measure:Number of subjects reporting adverse events<br>Timepoints:When the adverse event appears<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Record of adverse events that produce the interruption of participation<br>Measure:Interruption of participation in the study due to adverse events<br>Timepoints:When the adverse event happens<br>;<br>Outcome name:Measurement of vital signs<br>Measure:Modifications produced in the vital signs with compared to the beginning<br>Timepoints:Before and after treatment<br>;<br>Outcome name:Physical exams will be presented in listings for inspection.<br>Measure:Changes in the physical examination<br>Timepoints:Before and after treatment<br>