Docusate/Senna for the Treatment of Diabetic Gastroparesis

Study Overview
=================
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.

Official Title
-----------------
Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis

Conditions
-----------------
Diabetic Gastroparesis

Intervention / Treatment
-----------------
* Drug: senna/docusate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose<br>8.6/50 mg of senna/docusate, oral, twice daily | Drug: senna/docusate<br>* Stimulant laxative<br>* Other names: Senokot-S;|
| Experimental: Low-dose<br>8.6/50 mg of senna/docusate, oral, once daily | Drug: senna/docusate<br>* Stimulant laxative<br>* Other names: Senokot-S;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 28 days |