Docusate/Senna for the Treatment of Diabetic Gastroparesis

September 25, 2020 updated by: Aurora Health Care

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Aurora Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-dose
8.6/50 mg of senna/docusate, oral, twice daily
Drug: senna/docusate
Stimulant laxative
Other Names:
  • Senokot-S
Experimental: Low-dose
8.6/50 mg of senna/docusate, oral, once daily
Drug: senna/docusate
Stimulant laxative
Other Names:
  • Senokot-S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
Time Frame: 28 days
mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Use of Breakthrough Medication
Time Frame: 28 days
Change in the frequency of use of breakthrough medication - daily diary
28 days
Frequency of Bowel Movements
Time Frame: 28 days
Change in the frequency of bowel movements - daily diary
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurora Health Care

Investigators

  • Principal Investigator: Bradley Gose, MD, Aurora Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

August 17, 2018

Study Completion (Actual)

August 17, 2018

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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