Bethanechol for Eosinophilic Esophagitis

Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)

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.

Study Overview

• Status: Terminated
• Conditions: Eosinophilic Esophagitis (EoE)
• Intervention / Treatment: Drug: Bethanechol

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Bethanechol; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Composite Vital Signs to Day 7	Vital signs include temperature, heart rate, breathing rate, and blood pressure. This variables will be measured during the study in order to assess any negative systemic effects of the study drug. These measurements are assessed as a composite and not individually therefore are grouped together as one outcome measure.	Day 1 and Day 7

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Yehudith Assouline-Dayan, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: March 21, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Parasympathomimetics; Muscarinic Agonists; Bethanechol
• Other Study ID Numbers: Bethanechol