Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months (BALL)
2015年2月18日 更新者：UCB Pharma
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.
To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.
研究概览
研究类型
介入性
注册 (实际的)
69
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国
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Arkansas
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Hot Springs、Arkansas、美国
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Jonesboro、Arkansas、美国
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Little Rock、Arkansas、美国
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California
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Bakersfield、California、美国
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Crescent City、California、美国
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Huntington Beach、California、美国
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Los Angeles、California、美国
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Orange、California、美国
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Roseville、California、美国
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Stockton、California、美国
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Georgia
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Albany、Georgia、美国
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Gainesville、Georgia、美国
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Illinois
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Normal、Illinois、美国
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Missouri
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Bridgeton、Missouri、美国
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Nebraska
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Omaha、Nebraska、美国
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Oklahoma
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Oklahoma City、Oklahoma、美国
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South Carolina
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Barnwell、South Carolina、美国
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Spartanburg、South Carolina、美国
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Tennessee
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Kingsport、Tennessee、美国
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Texas
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Austin、Texas、美国
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Dallas、Texas、美国
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El Paso、Texas、美国
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San Antonio、Texas、美国
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Sugarland、Texas、美国
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Virginia
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Richmond、Virginia、美国
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 至 11个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Outpatient, male or female pediatric subject, aged from 6 to 11 months (6 months - < 1 year) at the randomization visit
- The subject must present at least one symptom most commonly associated with allergic rhinitis or chronic idiopathic urticaria
- Candidate for antihistamine treatment or received antihistamine in the past for similar symptoms as those presenting
Exclusion Criteria:
- Any clinically significant medical condition or abnormality other than the primary diagnosis for which an antihistamine is indicated
- Be initiating or changing the dose of an immunotherapy regimen during the course of the study (Visit 1 to Visit 4)
- Any Electrocardiogram (ECG) parameters, including a QTcF interval > 443 msec measured by an ECG obtained at the Screening Visit, outside the normal reference ranges
- Any clinical laboratory tests performed at Screening Visit, other than those related with the allergic condition, outside the reference ranges. Subjects having values outside the accepted reference range can be included if in the Investigator's opinion, they are of no clinical significance
- Personal history of seizure, febrile seizure or sleep apnea
- Below the lower 5th or above 95th percentile for body weight and/or height based upon CDC Growth Charts for Body Weight and Length
- Allergy or intolerance to levocetirizine dihydrochloride or its excipients, or to any other piperazine derivatives, such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine
Current or past intake (including exposure through breast milk) of the following medications within the specified wash-out period before the Randomization Visit (V2):
- Systemic corticosteroids within the past 28 days
- Leukotriene-receptor antagonists (e.g. montelukast [Singulair] or zafirlukast [Accolate] within the past 7 days)
- Mast-cell stabilizers (e.g. cromolyn or nedocromil) within the past 7 days
- Other antihistamines or cough and cold preparations (with the exception of single ingredient guaifenesin products), or over-the-counter (OTC) sleep aid medications within the past 7 days
- Systemic antibiotics within the past 7 days
- Other concomitant medications that will interfere with the study, in the opinion of the investigator
- Previous participation in another clinical/pharmacological trial within the past month prior to V1
- Have already participated in this study or participated in this study at another site
- Children of any member of the study site staff
- Sibling with sleep apnea or sudden infant death syndrome (SIDS)
Exposure to other conditions known to be potential risk factors for SIDS, such as but not limited to (this should be determined on a case by case basis taking into account the subject's entire medical history and environmental living conditions):
- Mothers who smoked or abused drugs during pregnancy
- Extremely young mothers (defined as age 19 or younger when pregnant)
- Children currently exposed to a caregiver which is a heavy cigarette smoker (defined as smoking at least a pack of cigarettes per day)
- Babies who sleep regularly on their face or are not put to sleep on their backs
- Premature birth gestational age ≤ 37 weeks) or low birth weight (below 10 percentile for gestational age)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：安慰剂
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Placebo oral liquid once a day for two weeks
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实验性的：左西替利嗪
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Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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心室率 (VR) 在第 4 次访视（第 14 天）或早期停药访视 (EDV) 时的基线变化
大体时间：基线，14 天
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基线，14 天
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
大体时间：Baseline, 14 days
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The RR interval refers to the respective time interval in the Electrocardiogram (ECG)
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Baseline, 14 days
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
大体时间：Baseline, 14 days
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The PR interval refers to the respective time interval in the Electrocardiogram (ECG)
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Baseline, 14 days
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
大体时间：Baseline, 14 days
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The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)
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Baseline, 14 days
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
大体时间：Baseline, 14 days
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The QT interval refers to the respective time in the Electrocardiogram (ECG)
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Baseline, 14 days
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
大体时间：Baseline, 14 days
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The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
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Baseline, 14 days
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Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)
大体时间：7 days
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The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
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7 days
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Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)
大体时间：14 days
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The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
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14 days
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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第 4 次访视（第 14 天）或早期停药访视 (EDV) 时总胆红素相对于基线的变化
大体时间：基线，14 天
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基线，14 天
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第 4 次访视（第 14 天）或早期停药访视 (EDV) 的丙氨酸转氨酶 (ALT) 相对于基线的变化
大体时间：基线，14 天
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基线，14 天
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)
大体时间：Baseline, 14 days
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Baseline, 14 days
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血尿素氮在第 4 次访视（第 14 天）或早期停药访视 (EDV) 时的基线变化
大体时间：基线，14 天
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基线，14 天
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第 4 次访视（第 14 天）或早期停药访视 (EDV) 时血肌酐的基线变化
大体时间：基线，14 天
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基线，14 天
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年3月1日
初级完成 (实际的)
2008年9月1日
研究完成 (实际的)
2008年9月1日
研究注册日期
首次提交
2008年2月22日
首先提交符合 QC 标准的
2008年2月22日
首次发布 (估计)
2008年3月4日
研究记录更新
最后更新发布 (估计)
2015年3月6日
上次提交的符合 QC 标准的更新
2015年2月18日
最后验证
2015年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.