NCT01348152已完成2 期
A Randomized, Double-Blinded, Placebo-Controlled Exploratory Study of Daikenchuto (TU-100) in Patients With Functional Constipation
Tsumura USA1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年9月最近更新:
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
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline to Day 28 in CSI total score
研究概览
简要总结
The primary objective of this study is to evaluate the improvement in the severity of constipation (from Baseline to Day 28), determined by the constipation severity instrument (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100 administered for 28 consecutive days in adult subjects with functional constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have severity of constipation in CSI score of 25 to 74 points.
- •Have the ability to orally ingest study medication, TU-100, and the SmartPill capsule.
- •Be male or female aged between 18 and 80 years old, inclusive.
- •Provide written informed consent before participation in the study after full explanations of the study purpose and procedures.
- •If a female is of childbearing potential and sexually active:
- •She must agree to practice a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, during their participation in the trial and for 4 weeks after receiving the last dose of study drug
- •She must have a negative serum pregnancy test before randomization.
- •If a male is sexually active with a female of childbearing potential:
- •He must agree to use a double barrier of birth control during the study and for 4 weeks after receiving the last dose of study drug.
- •He must not donate sperm during the study and for 4 weeks after receiving the last dose of study drug.
排除标准
- •Presence of strictures, fistulas, or physiological or mechanical bowel obstruction.
- •Presence of implanted or portable electro-mechanical medical devices.
- •History of gastric bezoar or swallowing disorders.
- •History of gastrointestinal surgery within 3 months of screening.
- •History of bowel resection.
- •Current pregnancy or lactation.
- •History of clinically significant alcohol or drug abuse within a year of screening.
- •Have any other condition that might adversely affect capacity to participate in this study, including liver disorders (with serum alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels exceeding 2.5 times the upper limit of normal [ULN]), kidney disorders, heart failure, blood disorders, or metabolic disorders.
- •Be diagnosed with cancer, ulcerative colitis, Crohn's disease, diverticulitis, scleroderma, Hirschsprung's disease, Chagas' disease, multiple sclerosis, Parkinson's disease, stroke, paraplegia, quadriplegia, insulin-dependent diabetes mellitus, untreated hypothyroidism, or any other systemic or psychiatric disorder which may, in the opinion of the investigator, interfere with the evaluation of TU-
- •Be taking any medication as follows: anticholinergic agents/medications with anticholinergic effect (list of prohibited drugs attached in Appendix G; antidepressants are permissible if the patient's symptoms are stable, and the doses are NOT changed during the course of the study), warfarin, prokinetics (i.e., Domperidone, Metoclopramide), narcotic analgesics, or any agent that might interfere with the evaluation of TU-100 in the opinion of the investigator.
- •Have a history of allergic reaction or hypersensitivity to ginseng, ginger, and Sichuan pepper.
- •Have severe dysphagia to food or pills.
- •Have participated in any other clinical study within 30 days before enrolling in this study.
- •Be unsuitable for participation in this trial for any reason, according to the investigator.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo TID
干预措施: Placebo (Drug)
DAIKENCHUTO (TU-100) 15 g/day
Experimental
TU-100 5g TID
干预措施: DAIKENCHUTO (TU-100) (Drug)
结局指标
主要结局
Change from baseline to Day 28 in CSI total score
时间窗: Up to 10 weeks
次要结局
- Change from baseline in GI transit time measured by SmartPill capsule.(Up to 10 weeks)
- Change from baseline to Day 28 in CRQOL total score.(Up to 10 weeks)
- Changes from baseline in stool frequency, stool consistency, severity of straining, and completeness of evacuation determined from entries in the bowel pattern diary.(Up to 10 weeks)
- Change from baseline to Day 28 in CSI subscale scores.(Up to 10 weeks)
- Change from baseline to Day 28 in CRQOL subscale scores.(Up to 10 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care UnitsChronic ConstipationNCT00354575National Taiwan University Hospital168
已完成
不适用
To Evaluate the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in AdultsConstipationNCT06761443Wecare Probiotics Co., Ltd.87
已完成
不适用
Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care PatientsPalliative CareConstipationNCT00902031University of Alberta70
已完成
2 期
An Evaluation of the Effectiveness of a Proprietary Probiotic Blend on Functional ConstipationFunctional ConstipationNCT02418507KGK Science Inc.100
已完成
2 期
A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus DecolonizationAntibiotic Resistant StrainNCT03063437Microbiome Health Research Institute9