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Docusate/Senna for the Treatment of Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342157
Recruitment Status : Terminated (low enrollment)
First Posted : November 14, 2017
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Aurora Health Care

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
Diabetic Gastroparesis Drug: senna/docusate Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : April 2, 2018
Actual Primary Completion Date : August 17, 2018
Actual Study Completion Date : August 17, 2018


Arm Intervention/treatment
Experimental: High-dose
8.6/50 mg of senna/docusate, oral, twice daily
Drug: senna/docusate
Stimulant laxative
Other Name: Senokot-S

Experimental: Low-dose
8.6/50 mg of senna/docusate, oral, once daily
Drug: senna/docusate
Stimulant laxative
Other Name: Senokot-S




Primary Outcome Measures :
  1. Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) [ Time Frame: 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 [ Time Frame: 28 days ]
    Change in the frequency of use of breakthrough medication - daily diary

  2. Frequency of bowel movements [ Time Frame: 28 days ]
    Change in the frequency of bowel movements - daily diary



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342157


Locations
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United States, Wisconsin
Aurora Health Care
Milwaukee, Wisconsin, United States, 53202
Sponsors and Collaborators
Aurora Health Care
Investigators
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Principal Investigator: Bradley Gose, MD Aurora Health Care
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Responsible Party: Aurora Health Care
ClinicalTrials.gov Identifier: NCT03342157    
Other Study ID Numbers: 17.120
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Bismuth subsalicylate
Sennoside A&B
Antidiarrheals
Gastrointestinal Agents
Cathartics