NCT01809587已完成3 期
Open Label Study to Assess the Safety and Efficacy of IQP-PO-101 in Regulating Bowel Movement Frequency
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bowel movement frequency
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A subject must have experienced 2 - 4 bowel movements per week and at least 2 of the following symptoms over the preceding 3 months (self-reported):
- •Excessive straining
- •Lumpy or hard stools
- •Sensation of anorectal obstruc-tion
- •A sense of incomplete evacua-tion of bowel movements
- •A need for digital manipulation to facilitate evacuation
- •Recorded between 4 and 9 defecations in the 14-day bowel movement diary during the run-in period
- •Subjects of childbearing potential must agree to use appropriate contraceptive methods during run-in and treatment period
- •Commitment to avoid the use of any laxatives and/ or other medicinal products/ supplements that may interfere with bowel movement frequency during the run-in and treatment period
- •Written informed consent.
排除标准
- •Known sensitivity to the ingredients of the device
- •Any organic gastrointestinal diseases, congenital or otherwise
- •Presence of occult blood on screening
- •Constipation that may have been drug-induced
- •Use of any laxative/ products that help ease bowel movements within 7 days of the screening visit
- •Constipation other than idiopathic constipation
- •Presence of other factor(s) that, in the in-vestigator's judgement, should preclude subject participation
研究组 & 干预措施
IQP-PO-101
Experimental
Day 1 to Day 7 - 1 sachet to be mixed in 250ml of water and consumed twice a day Day 8 to Day 28 - 1 sachet to be mixed in 250ml of water and consumed once a day Day 28 to Day 42 - no investigational product intake (post treatment observation only)
干预措施: IQP-PO-101 (Device)
结局指标
主要结局
Bowel movement frequency
时间窗: 6 weeks
Subjects will keep a record of the number of bowel movements, if any, from 00:00 hours to 23:59 hours (midnight to midnight) daily.
次要结局
- Evaluation of efficacy by subjects(4 weeks)
- Bristol Stool Form Scale(6 weeks)
- Straining at the start/ end of defecation(6 weeks)
- Pain during defecation(6 weeks)
- Feeling of incomplete evacuation(6 weeks)
- Evaluation of efficacy by investigator(4 weeks)
- Full blood count(4 weeks)
- Adverse events(6 weeks)
- Clinical chemistry(4 weeks)
- Safety evaluation by subjects(4 weeks)
- Safety evaluation by investigators(4 weeks)
研究者
研究点 (1)
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