Bethanechol for Eosinophilic Esophagitis

• Sponsor: University of Iowa (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02058537
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 4.9
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis (EoE)	Drug: Bethanechol	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. Change From Baseline Composite Vital Signs to Day 7 [Day 1 and 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• University of Iowa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assouline-Dayan, Yehudith, Clinical Assistant Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT02058537
• Other Study ID Numbers: Bethanechol
• First Posted: Feb 10, 2014
• Last Update Posted: Apr 22, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Esophagitis; Eosinophilic Esophagitis; Bethanechol

Study Results

Participant Flow

Arm/Group Title	Bethanechol
Arm/Group 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. 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.
Period Title: Overall Study
STARTED	3
COMPLETED	2
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Bethanechol
Arm/Group 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. 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.
Overall Participants	3
Age (participants) [Number]
<=18 years	0 0%
Between 18 and 65 years	2 66.7%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.67 (16.86)
Sex: Female, Male (Count of Participants)
Female	1 33.3%
Male	2 66.7%
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

We did not do the data analysis since the originating PI left the institution and the study was terminated.

Arm/Group Title	Bethanechol
Arm/Group 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. 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.
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

We did not do the data analysis since the originating PI left the institution and the study was terminated.

Arm/Group Title	Bethanechol
Arm/Group 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. 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.
Measure Participants	0

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

We did not do the data analysis since the originating PI left the institution and the study was terminated.

Arm/Group Title	Bethanechol
Arm/Group 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. 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.
Measure Participants	0

Adverse Events

Arm/Group Title	Bethanechol
Arm/Group 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. 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.
All Cause Mortality
	Bethanechol
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bethanechol
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Bethanechol
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.