Bethanechol for Eosinophilic Esophagitis

Eosinophilic Esophagitis (EoE) Clinical Trial

Official title:

Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02058537
• Other study ID #: Bethanechol
• Status: Terminated
• Phase: Phase 2
• First received: February 4, 2014
• Last updated: January 11, 2016
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: January 2016
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Eosinophilic Esophagitis (EoE)
• Esophagitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline composite vital signs to Day 7	Vital signs include temperature, heart rate, breathing rate, and blood pressure. This variables will be measured during the study in order to assess any negative systemic effects of the study drug. These measurements are assessed as a composite and not individually therefore are grouped together as one outcome measure.	Day 1 and Day 7	Yes
Primary	Change from Baseline high resolution esophageal manometry with impedance to Day 7	The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing.	Day 1 and Day 7	No
Secondary	Change from Baseline evaluation of esophageal function questionnaire to Day 7	This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.	Day 1 and Day 7	No