Bethanechol for Eosinophilic Esophagitis

NCT ID: NCT02058537

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

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.

Conditions

Eosinophilic Esophagitis (EoE)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bethanechol

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.

Group Type: EXPERIMENTAL

Bethanechol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Assouline-Dayan, Yehudith

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yehudith Assouline-Dayan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

Bethanechol

Identifier Type: -

Identifier Source: org_study_id