Docusate/Senna for the Treatment of Diabetic Gastroparesis
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/10/2019 |
| Start Date: | April 2, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Gary Dennison, CIP |
| Email: | gary.dennison@aurora.org |
| Phone: | 414-385-1913 |
Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis
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.
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.
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
We found this trial at
1
site
Milwaukee, Wisconsin 53215
Principal Investigator: Bradley Gose, MD
Phone: 414-649-6685
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