Docusate/Senna for the Treatment of Diabetic Gastroparesis
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: High-dose 8.6/50 mg of senna/docusate, oral, twice daily |
Drug: senna/docusate
Stimulant laxative
Other Names:
|
Experimental: Low-dose 8.6/50 mg of senna/docusate, oral, once daily |
Drug: senna/docusate
Stimulant laxative
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Aurora Health Care | Milwaukee | Wisconsin | United States | 53202 |
Sponsors and Collaborators
- Aurora Health Care
Investigators
- Principal Investigator: Bradley Gose, MD, Aurora Health Care
Study Documents (Full-Text)
More Information
Publications
None provided.- 17.120
Study Results
Participant Flow
Recruitment Details | Recruitment occurred from 11/01/2017 through 05/11/2020 at St Lukes Medical Center utilizing outpatient and inpatient referrals from practitioners. |
---|---|
Pre-assignment Detail | No enrolled participants were excluded from the study. |
Arm/Group Title | High-dose | Low-dose |
---|---|---|
Arm/Group Description | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative |
Period Title: Overall Study | ||
STARTED | 1 | 1 |
COMPLETED | 1 | 1 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | High-dose | Low-dose | Total |
---|---|---|---|
Arm/Group Description | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative | Total of all reporting groups |
Overall Participants | 1 | 1 | 2 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
1
100%
|
1
100%
|
2
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Full Range) ] | |||
Mean (Full Range) [years] |
51
|
49
|
50
|
Sex: Female, Male (Count of Participants) | |||
Female |
1
100%
|
1
100%
|
2
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (Count of Participants) | |||
United States |
1
100%
|
1
100%
|
2
100%
|
modified gastroparesis cardinal symptom index daily diary (mGCSI-DD) (participants) [Number] | |||
breakthrough medication use (participants) [Number] | |||
frequency of bowel habits (participants) [Number] |
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
Statistical analysis not appropriate on a sample size of 1 patient per arm. |
Arm/Group Title | High-dose | Low-dose |
---|---|---|
Arm/Group Description | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative |
Measure Participants | 0 | 0 |
Title | Frequency of Use of Breakthrough Medication |
---|---|
Description | Change in the frequency of use of breakthrough medication - daily diary |
Time Frame | 28 days |
Outcome Measure Data
Analysis Population Description |
---|
Statistical analysis not appropriate on a sample size of 1 patient per arm. |
Arm/Group Title | High-dose | Low-dose |
---|---|---|
Arm/Group Description | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative |
Measure Participants | 0 | 0 |
Title | Frequency of Bowel Movements |
---|---|
Description | Change in the frequency of bowel movements - daily diary |
Time Frame | 28 days |
Outcome Measure Data
Analysis Population Description |
---|
Statistical analysis not appropriate on a sample size of 1 patient per arm. |
Arm/Group Title | High-dose | Low-dose |
---|---|---|
Arm/Group Description | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | 35 days | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | High-dose | Low-dose | ||
Arm/Group Description | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative | ||
All Cause Mortality |
||||
High-dose | Low-dose | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1 (0%) | 0/1 (0%) | ||
Serious Adverse Events |
||||
High-dose | Low-dose | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1 (0%) | 0/1 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
High-dose | Low-dose | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1 (0%) | 0/1 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Bradley Gose |
---|---|
Organization | Advocate Aurora Health |
Phone | 414-385-2590 |
bradley.gose@aah.org |
- 17.120