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Bethanechol for Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT02058537
Recruitment Status : Terminated (Initial PI left, study not continued)
First Posted : February 10, 2014
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Assouline-Dayan, Yehudith, University of Iowa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis (EoE) Drug: Bethanechol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
Study Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7 [ Time Frame: Day 1 and 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.


Secondary Outcome Measures :
  1. Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7 [ Time Frame: Day 1 and Day 7 ]
    This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.


Other Outcome Measures:
  1. Change From Baseline Composite Vital Signs to Day 7 [ Time Frame: Day 1 and 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058537


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Yehudith Assouline-Dayan, MD University of Iowa
More Information
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Responsible Party: Assouline-Dayan, Yehudith, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02058537    
Other Study ID Numbers: Bethanechol
First Posted: February 10, 2014    Key Record Dates
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Bethanechol
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action