NCT01244217已完成2 期
An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Perennial Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- The number of clinically significant abnormalities for laboratory findings
研究概览
简要总结
Primary Objective:
- To evaluate safety (4 weeks)
Secondary Objectives:
- To evaluate the long-term safety (12 weeks)
- To evaluate the efficacy
- To characterize the pharmacokinetic profile
详细描述
The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Age 6 months - 2 years
Experimental
Patients between 6 months and 2 years old
干预措施: fexofenadine/Allegra (M016455) (Drug)
Age 2 - 11 years
Experimental
Patients between 2 and 11 years (and under 10.5 kg)
干预措施: fexofenadine/Allegra (M016455) (Drug)
Age 2 - 11 years (and over 10.5 kg)
Experimental
Patients between 2 and 11 years (and over 10.5 kg)
干预措施: fexofenadine/Allegra (M016455) (Drug)
结局指标
主要结局
The number of clinically significant abnormalities for laboratory findings
时间窗: 4 weeks
Number of patients with adverse events
时间窗: 4 weeks
次要结局
- Number of patients with adverse events(12 weeks)
- Changes from baseline in nasal symptom scores on patient diary(4 weeks)
- Pharmacokinetic parameters of fexofenadine at steady state; AUC(week 4 and 12)
- The number of clinically significant abnormalities for laboratory findings(12 weeks)
- Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator(week 2 and 4)
研究者
研究点 (15)
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