PER-042-03已完成1 期
STUDY RANDOMIZED, OF 3 PERIODS OF MULTIPLE DOSE, MULTICENTRIC TO EVALUATE THE SAFETY, TOLERABILITY AND THE PROFILE OF PLASMA CONCENTRATION OF MONTELUKAST ADMINSTRATED ONCE A DAY IN ORAL GRANULES TO CHILDREN FROM 3 TO 6 MONTHS OF AGE.
MERCK & CO.INC.,0 个研究点目标入组 0 人开始时间: 2003年8月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •a. The patient is a boy or girl of> 3 months to <6 months of age at the time of administration of the drug.
- •b. The parent / legal guardian accepts the patient´s participation in the study as indicated by the signature of the parent / legal guardian in the consent form. The patient and the parent / guardian are willing to comply with the procedures and can make scheduled clinic visits.
- •c. The good health of a patient (without taking into account his bronchiolitis) is determined based on medical history and physical examination.
- •d. The patient is within the 5 ´° and 95´ ° percentile height by weight.
- •e. The patient has received semi-solid foods, or soft foods for at least 1 week.
- •F. The patient has received applesauce or products containing apple at least twice before the administration of the medication in Visit 2.
- •g. The patient has active bronchiolitis or a history of bronchiolitis and asthma-like symptoms.
排除标准
- •a. The person in charge of patient care (parent / guardian) is, in opinion
- •of the researcher, mentally or legally disabled, so that it is not possible
- •Obtain informed consent.
- •j. The patient has used astemizole within 3 months prior to Visit 1 or
- •terfenadine, and / or loratadine, within the 10 days prior to Visit 1.
- •c. The patient has a history of any disease that, in the opinion of the
- •researcher, could confuse the results of the study or pose a risk
- •additional when administering montelukast to the patient.
- •d. The patient has significant or unexplained abnormalities in the examination
- •Pre-study physical and / or laboratory safety measurements (Appendices
- •and. The patient is in a situation (for example, is in the care of a
- •surrogate family, unreliable, in moving) or have a medical problem
- •which, in the opinion of the researcher, could interfere with their optimal participation
- •in the study.
- •F. The patient has a history of any disease clinically
- •significant of the gastrointestinal, cardiovascular, hepatic systems,
- •neurological, renal, genitourinary or hematologic or have a disease
- •pulmonary that is not bronchiolitis or has symptoms similar to asthma.
- •g. The patient has a history of a clinically serious adverse event
- •meaningful in relation to the administration of a medication either
- •commercial or research (for example, angioedema, anaphylaxis).
- •h. The patient has undergone surgery or has participated in another clinical study
- •within 8 weeks prior to Visit 1.
- •i. The patient has taken any medication that does not belong to the
- •allowed within the 14 days prior to Visit 1.
研究者
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