Docusate/Senna for the Treatment of Diabetic Gastroparesis

NCT03342157 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 17.120
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Frequency of Use of Breakthrough Medication

  28 days

• Frequency of Bowel Movements

  28 days

Study Arms (2)

High-dose

EXPERIMENTAL

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

Drug: senna/docusate

Low-dose

EXPERIMENTAL

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

Drug: senna/docusate

Interventions

senna/docusate DRUG

Stimulant laxative

Also known as: Senokot-S

High-dose; Low-dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Health Care

Milwaukee, Wisconsin, 53202, United States

Location

MeSH Terms

Interventions

doxidan

Limitations and Caveats

study stopped due to low enrollment

Results Point of Contact

• Title: Dr. Bradley Gose
• Organization: Advocate Aurora Health

bradley.gose@aah.org

414-385-2590

Study Officials

• Bradley Gose, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 14, 2017
• Study Start: April 2, 2018
• Primary Completion: August 17, 2018
• Study Completion: August 17, 2018
• Last Updated: October 3, 2024
• Results First Posted: October 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)