Trial Outcomes & Findings for Bethanechol for Eosinophilic Esophagitis (NCT NCT02058537)
NCT ID: NCT02058537
Last Updated: 2016-04-22
Results Overview
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.
TERMINATED
PHASE2
2 participants
Day 1 and Day 7
2016-04-22
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Bethanechol for Eosinophilic Esophagitis
Baseline characteristics by cohort
| Measure |
Bethanechol
n=3 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
|
Age, Continuous
|
30.67 years
STANDARD_DEVIATION 16.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 7Population: We did not do the data analysis since the originating PI left the institution and the study was terminated.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: We did not do the data analysis since the originating PI left the institution and the study was terminated.
This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 and Day 7Population: We did not do the data analysis since the originating PI left the institution and the study was terminated.
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.
Outcome measures
Outcome data not reported
Adverse Events
Bethanechol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place