Docusate/Senna for the Treatment of Diabetic Gastroparesis

Diabetic Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03342157
• Other study ID #: 17.120
• Status: Terminated
• Phase: Phase 2
• Start date: April 2, 2018
• Est. completion date: August 17, 2018

Study information

• Verified date: September 2020
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 17, 2018
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• senna/docusate
Stimulant laxative

Locations

Country	Name	City	State
United States	Aurora Health Care	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)	mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)	28 days
Secondary	Frequency of Use of Breakthrough Medication	Change in the frequency of use of breakthrough medication - daily diary	28 days
Secondary	Frequency of Bowel Movements	Change in the frequency of bowel movements - daily diary	28 days