Diabetic Gastroparesis
Conditions
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.
Interventions
DRUGsenna/docusate
Stimulant laxative
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
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 details
No enrolled participants were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| High-dose 8.6/50 mg of senna/docusate, oral, twice daily
senna/docusate: Stimulant laxative | 1 |
| Low-dose 8.6/50 mg of senna/docusate, oral, once daily
senna/docusate: Stimulant laxative | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | High-dose | Low-dose | Total | — |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants | — |
| Age, Continuous | 51 years | 49 years | 50 years | — |
| breakthrough medication use | — | — | — | — participants |
| frequency of bowel habits | — | — | — | — participants |
| modified gastroparesis cardinal symptom index daily diary (mGCSI-DD) | — | — | — | — participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 1 Participants | 1 Participants | 2 Participants | — |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants | — |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
Time frame: 28 days
Population: Statistical analysis not appropriate on a sample size of 1 patient per arm.
Secondary
Frequency of Bowel Movements
Change in the frequency of bowel movements - daily diary
Time frame: 28 days
Population: Statistical analysis not appropriate on a sample size of 1 patient per arm.
Secondary
Frequency of Use of Breakthrough Medication
Change in the frequency of use of breakthrough medication - daily diary
Time frame: 28 days
Population: Statistical analysis not appropriate on a sample size of 1 patient per arm.