NCT00757562已完成3 期
Multiple-Dose Safety and Tolerance Study of Desloratadine in Atopic Pediatric Subjects and Pediatric Subjects With Chronic Idiopathic Urticaria, Ages >=2 to <12 Years, Who Are Poor Metabolizers of Desloratadine
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 97
- 主要终点
- Safety and Tolerance
研究概览
简要总结
This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must:
- •have been previously identified through the previous study P03031 to be atopic or with chronic idiopathic urticaria and be a poor metabolizer of desloratadine.
- •have clinical laboratory tests within normal limits.
- •be in good health, free of any clinically significant disease that could interfere with the study.
- •normal 12-lead ECG
排除标准
- •Subjects who:
- •have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to treatment.
- •have taken any medication that is restricted by the protocol or failed to satisfy washout requirements.
- •are allergic to desloratadine.
- •have used a loratadine- or desloratadine-containing product within the past 30 days.
- •are female and menstruating.
研究组 & 干预措施
DL
Experimental
Desloratadine syrup once daily
干预措施: desloratadine (Drug)
Placebo
Placebo Comparator
placebo syrup once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerance
时间窗: Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36).
次要结局
- Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36.(Days 15 and Days 36)
研究者
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