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

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 2001年7月17日最近更新: 2023年9月4日

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•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.

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