Study Stopped
Initial PI left, study not continued
Bethanechol for Eosinophilic Esophagitis
Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
February 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
April 22, 2016
CompletedApril 22, 2016
March 1, 2016
5 months
February 4, 2014
March 21, 2016
March 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7
Day 1 and Day 7
Other Outcomes (1)
Change From Baseline Composite Vital Signs to Day 7
Day 1 and Day 7
Study Arms (1)
Bethanechol
EXPERIMENTALOral 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ron Schey
- Organization
- Temple University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Yehudith Assouline-Dayan, MD
University of Iowa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
February 4, 2014
First Posted
February 10, 2014
Study Start
February 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
April 22, 2016
Results First Posted
April 22, 2016
Record last verified: 2016-03