Bethanechol for Eosinophilic Esophagitis

Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)

Sponsors

Lead Sponsor: University of Iowa

Source University of Iowa
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.

Overall Status Terminated
Start Date 2014-02-01
Completion Date 2014-07-01
Primary Completion Date 2014-07-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7 Day 1 and Day 7
Secondary Outcome
Measure Time Frame
Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7 Day 1 and Day 7
Enrollment 2
Condition
Intervention

Intervention Type: Drug

Intervention Name: Bethanechol

Description: 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.

Arm Group Label: Bethanechol

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yehudith Assouline-Dayan, MD Principal Investigator University of Iowa
Location
Facility: University of Iowa Hospitals and Clinics
Location Countries

United States

Verification Date

2016-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Iowa

Investigator Full Name: Assouline-Dayan, Yehudith

Investigator Title: Clinical Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Bethanechol

Type: Experimental

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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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