Bethanechol for Eosinophilic Esophagitis

Phase 2

Terminated

• Conditions: Eosinophilic Esophagitis (EoE)
• Interventions: Drug: Bethanechol

• Registration Number: NCT02058537
• Lead Sponsor: University of Iowa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-03
• Results First Submitted: 2016-03-21
• Results First Submitted QC: 2016-03-21
• Last Update Submitted: 2016-03-21
• Results First Posted: 2016-04-22
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bethanechol	Bethanechol	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7	Day 1 and 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7	Day 1 and Day 7	This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States