Bethanechol for Eosinophilic Esophagitis
Information source: University of Iowa
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eosinophilic Esophagitis (EoE)
Intervention: Bethanechol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Iowa Official(s) and/or principal investigator(s): Yehudith Assouline-Dayan, MD, Principal Investigator, Affiliation: University of Iowa
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.
Clinical Details
Official title: Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from Baseline high resolution esophageal manometry with impedance to Day 7
Secondary outcome: Change from Baseline evaluation of esophageal function questionnaire to Day 7
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States
Additional Information
Starting date: February 2014
Last updated: June 8, 2015
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