Back to resultsDocusate/Senna for the Treatment of Diabetic Gastroparesis
Primary Purpose
Diabetic Gastroparesis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
senna/docusate
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Gastroparesis
Eligibility Criteria
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
Sites / Locations
- Aurora Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High-dose
Low-dose
Arm Description
8.6/50 mg of senna/docusate, oral, twice daily
8.6/50 mg of senna/docusate, oral, once daily
Outcomes
Primary Outcome Measures
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
Secondary Outcome Measures
Frequency of Use of Breakthrough Medication
Change in the frequency of use of breakthrough medication - daily diary
Frequency of Bowel Movements
Change in the frequency of bowel movements - daily diary
Full Information
NCT ID
NCT03342157
First Posted
November 10, 2017
Last Updated
September 25, 2020
Sponsor
Aurora Health Care
1. Study Identification
Unique Protocol Identification Number
NCT03342157
Brief Title
Docusate/Senna for the Treatment of Diabetic Gastroparesis
Official Title
Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
August 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurora Health Care
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-dose
Arm Type
Experimental
Arm Description
8.6/50 mg of senna/docusate, oral, twice daily
Arm Title
Low-dose
Arm Type
Experimental
Arm Description
8.6/50 mg of senna/docusate, oral, once daily
Intervention Type
Drug
Intervention Name(s)
senna/docusate
Other Intervention Name(s)
Senokot-S
Intervention Description
Stimulant laxative
Primary Outcome Measure Information:
Title
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
Description
mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Frequency of Use of Breakthrough Medication
Description
Change in the frequency of use of breakthrough medication - daily diary
Time Frame
28 days
Title
Frequency of Bowel Movements
Description
Change in the frequency of bowel movements - daily diary
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Gose, MD
Organizational Affiliation
Aurora Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Docusate/Senna for the Treatment of Diabetic Gastroparesis
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