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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

Page last updated: August 23, 2015

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