Docusate/Senna for the Treatment of Diabetic Gastroparesis

• Status: Terminated
• Trial end date: 2018-08-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aurora Health Care
• Treatments: Bismuth subsalicylate; Senna Extract; Sennoside A&B; Sennosides

Criteria

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