NCT03342157

Docusate/Senna for the Treatment of Diabetic Gastroparesis

Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Gastroparesis

Interventions

Type	Name	Description
DRUG	senna/docusate	Stimulant laxative

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-08-17
• Completion: 2018-08-17
• First posted: 2017-11-14
• Last updated: 2024-10-03
• Results posted: 2020-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study