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Bethanechol for Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT02058537
Recruitment Status : Terminated (Initial PI left, study not continued)
First Posted : February 10, 2014
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Assouline-Dayan, Yehudith, University of Iowa

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Eosinophilic Esophagitis (EoE)
Intervention Drug: Bethanechol
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bethanechol
Hide 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
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Bethanechol
Hide 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 Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years 0
Between 18 and 65 years 2
>=65 years 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
30.67  (16.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Other Pre-specified Outcome
Title Change From Baseline Composite Vital Signs to Day 7
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bethanechol
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bethanechol
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bethanechol
Affected / at Risk (%)
Total   0/3 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ron Schey
Organization: Temple University Hospital
Phone: 215-540-0120
EMail: Ron.schey@tuhs.temple.edu
Layout table for additonal information
Responsible Party: Assouline-Dayan, Yehudith, University of Iowa
ClinicalTrials.gov Identifier: NCT02058537     History of Changes
Other Study ID Numbers: Bethanechol
First Submitted: February 4, 2014
First Posted: February 10, 2014
Results First Submitted: March 21, 2016
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016