Eosinophilic Esophagitis (EoE)
Conditions
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.
Interventions
DRUGBethanechol
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.
Sponsors
University of Iowa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7 | Day 1 and Day 7 | This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Composite Vital Signs to Day 7 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Bethanechol |
|---|---|
| Age, Categorical <=18 years | 0 participants |
| Age, Categorical >=65 years | 0 participants |
| Age, Categorical Between 18 and 65 years | 2 participants |
| Age, Continuous | 30.67 years STANDARD_DEVIATION 16.86 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: Day 1 and Day 7
Population: We did not do the data analysis since the originating PI left the institution and the study was terminated.
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.
Time frame: Day 1 and Day 7
Population: We did not do the data analysis since the originating PI left the institution and the study was terminated.
Other Pre-specified
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.
Time frame: Day 1 and Day 7
Population: We did not do the data analysis since the originating PI left the institution and the study was terminated.