JPRN-jRCTs031200168已完成未知
Study confirming efficacy and safety by switching to lubiprostone in elderly chronic constipation patients taking stimulant laxatives (Switch Study) - Switch Study
Masaki Maruyama0 个研究点目标入组 106 人开始时间: 2020年10月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 106
研究概览
简要总结
The switch to lubiprostone alone in patients taking continuous stimulant laxatives has no major safety issues, maintaining short-term SBM and bristol scale, but after 4 weeks a trend was seen to be lowering SBM and quality of life.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 65age old 至 < 90age old（—）
- 性别
- All
入选标准
- •1) Patients diag nosed with chronic constipation
- •2) Patients who, after receiving a sufficient explanation before participating in this study, can obtain a free written informed consent of themselves
- •3) Patients who can comply with the compliance requirements during this study, receive medical examinations, tests, and report symptoms as prescribed in this study plan.
- •4) Patients over the ag e of 65 and under 90 at the time of obtaining consent (reg ardless of g ender)
- •5) Patients who can stop taking stimulant laxatives during the study drug administration period
- •6) Patients who continue to take stimulant laxative for at least 2 weeks before study drug administration
排除标准
- •1) Patients with severe cardiopulmonary disorders
- •2) Patients with confirmed or suspected intestinal obstruction due to tumor, hernia, etc.
- •3) Patients with a history of hypersensitivity to the components of the drug used
- •4) Patients who participated in other clinical trials and received study drug within 1 month of the start of this study (calculated from the study drug administration date)
- •5) Patients taking lubiprostone within 3 months of participating in this study
- •6) Patients with moderate or severe liver dysfunction
- •7) Patients with severe renal dysfunction
- •8) Other patients who are judg ed to be inappropriate by the investig ator or the investig ator
研究者
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