Docusate/Senna for the Treatment of Diabetic Gastroparesis (NCT03342157) | Clinical Trial Compass
TerminatedPhase 2
Docusate/Senna for the Treatment of Diabetic Gastroparesis
Stopped: low enrollment
United States2 participantsStarted 2018-04-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.