PER-086-06已完成未知
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 to 5 Years
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2006年11月17日最近更新:
试验速览
- 阶段
- 未知
- 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 from 2 years (24 months) to 5 years (71 months) of age.
- •b) The parent / legal guardian agrees that the patient participate in the study as indicated by the signature of the parent / legal guardian in the informed consent.
- •c) The patient has a history of episodic asthma symptoms, so that in the 12 months prior to Visit 1, the patient had at least 3 but no more than 6 symptoms of asthma episodes for approximately 3 days.
- •d) In the 12 months prior to Visit 1, the patient had at least one treatment with corticosteroids or was hospitalized at least 1 time because of asthma.
- •e) It is determined that in other aspects the patient is well, with stable health and seems to be able to successfully complete this test.
- •f) Parents / guardians are able to read and understand the questions that appear in the diary.
- •g) Patients can chew a tablet.
排除标准
- •a) The parent / guardian is mentally or legally incapacitated, which prevents the signing of informed consent.
- •b) The patient is hospitalized.
- •c) The patient has participated in a clinical trial that involves a drug under investigation or commercialized within the 8 weeks prior to Visit 1.
- •d) The patient has had some major surgical procedure within 4 weeks prior to Visit 1.
- •e) The patient has some active, clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary or hematological systems or has hypertension.
- •f) The patient has a history of some clinically significant adverse event of a serious nature related to the administration of any drug marketed or under investigation or, otherwise, is sensitive to drugs marketed or under investigation.
- •g) The patient presents significant or unexplained abnormalities in the physical examination of Visit 1
- •h) The patient has a history of persistent symptoms of asthma so that diurnal symptoms occur> once a week and nocturnal symptoms occur> twice a month.
- •i) The patient presents any acute or chronic active lung disorder, different from asthma, documented by history or physical examination.
- •j) The patient has required, in the past, intubation due to asthma.
- •k The patient has some unresolved sign or symptom of an acute episode of asthma in the last 2 weeks.
- •l) The patient has some sign or symptom of an infection of the respiratory tract in the last 2 weeks.
- •m) The patient has some evidence of active sinus disease, clinically important in the last 4 weeks.
- •n) The patient is receiving immunotherapy.
- •o) The patient has used long-term control drugs in the last 2 weeks or for> 4 months, cumulatively, in the 12 months prior to Visit 1.
- •p) The patient is in a situation or has a condition that may interfere with their optimal participation in the study.
- •q) The patient and / or the parent / guardian are unable or unwilling to comply with the study procedures.
- •r) The patient has significant or unexplained abnormalities in the laboratory safety tests.
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