Docusate/Senna for the Treatment of Diabetic Gastroparesis

NCT03342157 — Phase 2, Terminated, 2 participants, Wake Forest University Health Sciences

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

Registry	NCT03342157
Status	Terminated - low enrollment
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	2 (Actual)
Sponsor	Wake Forest University Health Sciences (Other)
Conditions	Diabetic Gastroparesis
Interventions	senna/docusate (Drug)
Dates	start 2018-04-02, primary completion 2018-08-17, completion 2018-08-17, first posted 2017-11-14, last updated 2024-10-03
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
High-dose	Experimental	Drug: senna/docusate	8.6/50 mg of senna/docusate, oral, twice daily
Low-dose	Experimental	Drug: senna/docusate	8.6/50 mg of senna/docusate, oral, once daily

senna/docusate (Drug), also known as Senokot-S: Stimulant laxative

+Outcome measures

Primary outcomes

Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) [28 days]: mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)

Secondary outcomes

Frequency of Use of Breakthrough Medication [28 days]: Change in the frequency of use of breakthrough medication - daily diary
Frequency of Bowel Movements [28 days]: Change in the frequency of bowel movements - daily diary

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Posted results

Participant flow

Milestone	High-dose	Low-dose
Started	1	1
Completed	1	1
Not completed	0	0

Outcome results

Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) (Primary)
Frequency of Use of Breakthrough Medication (Secondary)
Frequency of Bowel Movements (Secondary)

Adverse events

Time frame: 35 days

Arm	Deaths	Serious adverse events	Other adverse events
High-dose	0/1 (0.0%)	0/1 (0.0%)	0/1 (0.0%)
Low-dose	0/1 (0.0%)	0/1 (0.0%)	0/1 (0.0%)

Limitations and caveats: study stopped due to low enrollment

+Locations (1)

Facility	City	Country	Status
Aurora Health Care	Milwaukee, Wisconsin	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2018-05-29)
Informed Consent Form (PDF, 2017-10-23)

+Investigators

Bradley Gose, MD, Principal investigator, Wake Forest University Health Sciences