Status:

TERMINATED

Docusate/Senna for the Treatment of Diabetic Gastroparesis

Lead Sponsor:

Wake Forest University Health Sciences

Conditions:

Diabetic Gastroparesis

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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, d...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 2 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 17 2018

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT03342157

Start Date

April 2 2018

End Date

August 17 2018

Last Update

October 3 2024

Active Locations (1)

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Aurora Health Care

Milwaukee, Wisconsin, United States, 53202