Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
研究概览
简要总结
The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label study, participants will be randomized into high and low dose groups to assess for ideal dosing and tolerability. It is the overall goal of this study to select the most promising dose-strength for the treatment of mild through severe gastroparesis.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, male and non-pregnant, non-lactating females
- •Diagnosis of type 1 or type 2 diabetes mellitus
- •Clinical diagnosis of diabetic gastroparesis
排除标准
- •Diagnosed idiopathic gastroparesis
- •A history or inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
- •A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed rectal bleeding
- •Gastrointestinal cancer
- •Any active cancer
- •Prior gastric surgery
- •End-stage heart disease, liver disease, lung disease
- •Known or suspected drug abuse
- •Any condition requiring use of daily narcotics
- •Concurrent usage of mineral oil or products containing mineral oil
- •Current or recent (within the last 3 months) usage of Senokot-S, docusate or senna
研究组 & 干预措施
High-dose
8.6/50 mg of senna/docusate, oral, twice daily
干预措施: senna/docusate (Drug)
Low-dose
8.6/50 mg of senna/docusate, oral, once daily
干预措施: senna/docusate (Drug)
结局指标
主要结局
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
时间窗: 28 days
mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
次要结局
- Frequency of Use of Breakthrough Medication(28 days)
- Frequency of Bowel Movements(28 days)