Docusate/Senna for the Treatment of Diabetic Gastroparesis
- Conditions
- Diabetic Gastroparesis
- Interventions
- Drug: senna/docusate
- Registration Number
- NCT03342157
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose senna/docusate 8.6/50 mg of senna/docusate, oral, once daily High-dose senna/docusate 8.6/50 mg of senna/docusate, oral, twice daily
- Primary Outcome Measures
Name Time Method Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) 28 days mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
- Secondary Outcome Measures
Name Time Method Frequency of Use of Breakthrough Medication 28 days Change in the frequency of use of breakthrough medication - daily diary
Frequency of Bowel Movements 28 days Change in the frequency of bowel movements - daily diary
Trial Locations
- Locations (1)
Aurora Health Care
🇺🇸Milwaukee, Wisconsin, United States