Bethanechol for Eosinophilic Esophagitis

University of Iowa

Status and phase: Terminated; Phase 2

Conditions: Eosinophilic Esophagitis (EoE)

Treatments: Drug: Bethanechol

Study type: Interventional

Funder types: Other

Identifiers

NCT02058537

Bethanechol

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Bethanechol

Experimental group

Description:

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.

Treatment:

Drug: Bethanechol