NCT01070615已完成3 期
A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation
Movetis2 个研究点 分布在 1 个国家目标入组 693 人开始时间: 1998年6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
- 693
- 试验地点
- 2
研究概览
简要总结
Objectives: Evaluation of the clinical long-term safety, tolerability, patient satisfaction, pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg once daily to patients with chronic constipation
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 or non-pregnant, non-breast-feeding female outpatients of at least 18 years of age
- •Patient had completed the entire treatment period of the PRU-INT-6 study or the PRU-INT-12 study .
排除标准
- •Patients with impaired renal function
- •Patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
- •Females of child-bearing potential without adequate contraceptive protection during the study.
研究者
研究点 (2)
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