Docusate/Senna for the Treatment of Diabetic Gastroparesis

Sponsor
Aurora Health Care (Other)
Overall Status
Terminated
CT.gov ID
NCT03342157
Collaborator
(none)
2
1
2
4.5
0.4

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

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis
Actual Study Start Date :
Apr 2, 2018
Actual Primary Completion Date :
Aug 17, 2018
Actual Study Completion Date :
Aug 17, 2018

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:
  • Senokot-S
  • Experimental: Low-dose

    8.6/50 mg of senna/docusate, oral, once daily

    Drug: senna/docusate
    Stimulant laxative
    Other Names:
  • Senokot-S
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Frequency of Use of Breakthrough Medication [28 days]

      Change in the frequency of use of breakthrough medication - daily diary

    2. Frequency of Bowel Movements [28 days]

      Change in the frequency of bowel movements - daily diary

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    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.
    Responsible Party:
    Aurora Health Care
    ClinicalTrials.gov Identifier:
    NCT03342157
    Other Study ID Numbers:
    • 17.120
    First Posted:
    Nov 14, 2017
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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
    2. Secondary Outcome
    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
    3. Secondary Outcome
    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

    study stopped due to low enrollment

    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
    Email bradley.gose@aah.org
    Responsible Party:
    Aurora Health Care
    ClinicalTrials.gov Identifier:
    NCT03342157
    Other Study ID Numbers:
    • 17.120
    First Posted:
    Nov 14, 2017
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Sep 1, 2020