drugset / Trial / NCT03342157

Docusate/Senna for the Treatment of Diabetic Gastroparesis

NCT03342157

Phase 2 Terminated 2 enrolled Wake Forest University Health Sciences
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2018-04-02
Primary completion
2018-08-17
Completion
2018-08-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Docusate Sodium Unknown 50 mg Oral
Subject Senna Traditional medicine (herbal / TCM) 8.6 mg Oral

Indications