Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-02 @ 7:29 AM
Study NCT ID:
NCT03342157
Status:
TERMINATED
Last Update Posted:
2024-10-03
First Post:
2017-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Docusate/Senna for the Treatment of Diabetic Gastroparesis
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: