Trial Outcomes & Findings for Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed. (NCT NCT02017379)
NCT ID: NCT02017379
Last Updated: 2021-03-04
Results Overview
Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa .
TERMINATED
NA
4 participants
45 minutes
2021-03-04
Participant Flow
The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Participant milestones
| Measure |
Erythromycin
Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure
Erythromycin
|
Metoclopromide
Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy
Metoclopromide
|
Control
no medications will be given prior to endoscopy
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 45 minutesPopulation: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa .
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 45 minutesPopulation: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 45 minutesPopulation: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Ability to identify the source of bleeding
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hoursPopulation: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Need for second-look endoscopy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hoursPopulation: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Mean number of blood units transfused
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
All cause mortality
Outcome measures
Outcome data not reported
Adverse Events
Erythromycin
Metoclopromide
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Research Compliance Officer
Texas Tech University Health Sciences Center at El Paso
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place