|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT02058537 |
|
Date of registration:
|
04/02/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Bethanechol for Eosinophilic Esophagitis
|
|
Scientific title:
|
Bethanechol for Treatment of Eosinophilic Esophagitis (EoE) |
|
Date of first enrolment:
|
February 2014 |
|
Target sample size:
|
2 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02058537 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Yehudith Assouline-Dayan, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Iowa |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Eosinophilic Esophagitis (EoE)
|
|
Intervention(s)
|
|
Drug: Bethanechol
|
|
Primary Outcome(s)
|
|
Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7
[Time Frame: Day 1 and Day 7]
|
|
Secondary Outcome(s)
|
|
Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7
[Time Frame: Day 1 and Day 7]
|
|
Secondary ID(s)
|
|
Bethanechol
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|