NCT00987844已完成3 期
A Study to Evaluate the Long-Term Tolerability, Safety, Patient Satisfaction, Pharmacokinetics, and Use Patterns of Oral Prucalopride Tablets in Patients With Chronic Constipation
Movetis2 个研究点 分布在 1 个国家目标入组 1,775 人开始时间: 1998年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,775
- 试验地点
- 2
- 主要终点
- Safety: adverse events, lab tests, vital signs, ECGs
研究概览
简要总结
Objectives: To evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (CC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
- •Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods.
排除标准
- •Patient with impaired renal function
- •Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
- •Female of childbearing potential without adequate contraceptive protection during the study.
- •Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.
结局指标
主要结局
Safety: adverse events, lab tests, vital signs, ECGs
时间窗: 24 months
次要结局
- Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride(24 months)
- Pharmacokinetics: Prucalopride plasmaconcentrations(24 months)
研究者
研究点 (2)
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