Docusate/Senna for the Treatment of Diabetic Gastroparesis

Wake Forest University (WFU)

Status and phase: Terminated; Phase 2

Conditions: Diabetic Gastroparesis

Treatments: Drug: senna/docusate

Study type: Interventional

Funder types: Other

Identifiers

NCT03342157

17.120

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

High-dose

Experimental group

Description:

8.6/50 mg of senna/docusate, oral, twice daily

Treatment:

Drug: senna/docusate

Low-dose

Experimental group

Description:

8.6/50 mg of senna/docusate, oral, once daily

Treatment:

Drug: senna/docusate