NCT00871325已完成1 期
Effect of Gastrointestinal Nerve Modulation With DAIKENCHUTO (TU-100) on Gastrointestinal and Colonic Transit in Humans
Tsumura USA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gastric emptying of solid
研究概览
简要总结
The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject is willing and able to provide written informed consent
- •Males and non-pregnant, non-breastfeeding females;
- •Subject is willing to undergo multiple radionuclide scans
- •Subject BMI is between 18 and 35 kg/m2
- •Subject has a negative urine drug screen
- •Subject has screening laboratory values that are within normal range for the analyzing laboratory
排除标准
- •Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
- •Unable to withdraw medications 48 hours prior to the study:
- •Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
- •Analgesic drugs including opiates, NSAID, COX 2 inhibitors
- •GABAergic agents
- •Benzodiazepines
- •NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
- •Female subjects who are pregnant or breast feeding.
- •Clinical evidence (including physical exam, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
- •History of allergic reactions to ginseng, ginger, and Sichuan pepper.
- •History of lactose intolerance.
- •Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
- •Subjects who have participated in another clinical study within the past 30 days.
研究组 & 干预措施
Daikenchuto (TU-100) 7.5g/day
Experimental
Daikenchuto (TU-100) 2.5g TID (7.5g/day)
干预措施: Daikenchuto (TU-100) (Drug)
Daikenchuto (TU-100) 15g/day
Experimental
Daikenchuto (TU-100) 5g TID (15g/day)
干预措施: Daikenchuto (TU-100) (Drug)
Placebo
Placebo Comparator
Placebo TID
干预措施: Placebo (Drug)
结局指标
主要结局
Gastric emptying of solid
时间窗: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
Colonic geometric center at 24 hours
时间窗: 4 hrs, 8 hrs, and 24 hrs
Ascending colon emptying
时间窗: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs
次要结局
- Stool frequency(Day 1, Day 2, Day 3, Day 4, Day 5)
- Stool consistency(Day 1, Day 2, Day 3, Day 4, Day 5)
- Colonic geometric center at 4 hours and 48 hours(1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs)
- Colonic filling at 6 hours(1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Effect of TU-100 on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Females With ConstipationGastric EmptyingWhole Gut TransitSmall Bowel TransitColonic TransitRectal ComplianceRectal SensationFunctional ConstipationNCT01139216Tsumura USA45
已完成
1 期
Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)Digestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAbdominal PainIrritable Bowel SyndromeNCT01890837Tsumura USA40
已完成
2 期
A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel SyndromeIrritable Bowel Syndrome in FemalesNCT02074579Tsumura USA101
Unknown
不适用
Probiotics in IgA NephropathyIgA NephropathyNCT01781312Uppsala University Hospital20
已完成
2 期
Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate HypertensionDiabetes MellitusNCT03462069Sanofi41