Bethanechol for Eosinophilic Esophagitis

Study Overview
=================
Brief Summary
-----------------
The primary goals of this study are to ease the symptoms of patients with Eosinophilic Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those symptoms.

Official Title
-----------------
Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)

Conditions
-----------------
Eosinophilic Esophagitis (EoE)

Intervention / Treatment
-----------------
* Drug: Bethanechol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Age 18-75 Symptoms associated with EoE such as dysphagia, heartburn, vomiting, abdominal pain, food impaction Subject has signed informed consent for the administration of bethanechol that informs the patient of potential adverse events Clinically or pathologically proven EoE Exclusion Criteria: Known allergy to bethanechol Asthma Pregnant or breast-feeding women Severe neurological problems Severe diabetes Achalasia Known allergy to lidocaine or other local anesthetic Hypothyroidism Peptic ulcer Pronounced bradycardia or hypotension Vasomotor instability Coronary artery disease Epilepsy Parkinsonism Weakened gastrointestinal or bladder wall Mechanical obstruction of the gastrointestinal tract or bladder neck Urinary bladder surgery in the 6 months prior to the study Gastrointestinal resection and anastomosis Spastic gastrointestinal disturbances Acute inflammatory lesions of the gastrointestinal tract Peritonitis Marked vagotonia

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bethanechol<br>Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg. | Drug: Bethanechol<br>* Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7 | The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing. | Day 1 and Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7 | This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness. | Day 1 and Day 7 |