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
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis (EoE)||Drug: Bethanechol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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.
- 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.
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
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Yehudith Assouline-Dayan, MD||University of Iowa|