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Bethanechol for Eosinophilic Esophagitis

Primary Purpose

Eosinophilic Esophagitis (EoE)

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bethanechol
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis (EoE)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bethanechol

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 4, 2014
Last Updated
March 21, 2016
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT02058537
Brief Title
Bethanechol for Eosinophilic Esophagitis
Official Title
Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Initial PI left, study not continued
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis (EoE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bethanechol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bethanechol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7
Description
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.
Time Frame
Day 1 and Day 7
Secondary Outcome Measure Information:
Title
Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7
Description
This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.
Time Frame
Day 1 and Day 7
Other Pre-specified Outcome Measures:
Title
Change From Baseline Composite Vital Signs to Day 7
Description
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.
Time Frame
Day 1 and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehudith Assouline-Dayan, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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Bethanechol for Eosinophilic Esophagitis

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