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low enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose | Experimental | 8.6/50 mg of senna/docusate, oral, twice daily |
|
| Low-dose | Experimental | 8.6/50 mg of senna/docusate, oral, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senna/docusate | Drug | Stimulant laxative |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Use of Breakthrough Medication | Change in the frequency of use of breakthrough medication - daily diary | 28 days |
| Frequency of Bowel Movements | Change in the frequency of bowel movements - daily diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Gose, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Health Care | Milwaukee | Wisconsin | 53202 | United States |
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No enrolled participants were excluded from the study.
Recruitment occurred from 11/01/2017 through 05/11/2020 at St Lukes Medical Center utilizing outpatient and inpatient referrals from practitioners.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-dose | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative |
| FG001 | Low-dose | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-dose | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative |
| BG001 | Low-dose | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) | mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5) | Statistical analysis not appropriate on a sample size of 1 patient per arm. | Posted | 28 days |
|
35 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-dose | 8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative |
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study stopped due to low enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bradley Gose | Advocate Aurora Health | 414-385-2590 | bradley.gose@aah.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2018 | Aug 7, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2017 | Aug 7, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C011803 | doxidan |
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| 28 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| modified gastroparesis cardinal symptom index daily diary (mGCSI-DD) | Statistical analysis not appropriate on a sample size of 1. | Statistical analysis not appropriate on a sample size of 1. | Number | participants |
|
| breakthrough medication use | Statistical analysis not appropriate on a sample size of 1. | Statistical analysis not appropriate on a sample size of 1. | Number | participants |
|
| frequency of bowel habits | Statistical analysis not appropriate on a sample size of 1. | Statistical analysis not appropriate on a sample size of 1. | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Secondary | Frequency of Use of Breakthrough Medication | Change in the frequency of use of breakthrough medication - daily diary | Statistical analysis not appropriate on a sample size of 1 patient per arm. | Posted | 28 days |
|
|
| Secondary | Frequency of Bowel Movements | Change in the frequency of bowel movements - daily diary | Statistical analysis not appropriate on a sample size of 1 patient per arm. | Posted | 28 days |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Low-dose | 8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative | 0 | 1 | 0 | 1 | 0 | 1 |
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