Trial Outcomes & Findings for Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy (NCT NCT01631994)
NCT ID: NCT01631994
Last Updated: 2023-04-11
Results Overview
Time for transit through small intestine.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Day 1
Results posted on
2023-04-11
Participant Flow
This study was ended early, only 6 patients were enrolled, 2 to the research arm, 4 to the control arm.
Participant milestones
| Measure |
Oral Dissolving Metoclopramide
Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.
metoclopramide: 1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.
|
Control Group
This is the control group that will only ingest the capsule during video capsule endoscopy.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy
Baseline characteristics by cohort
| Measure |
Oral Dissolving Metoclopramide
n=2 Participants
Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.
metoclopramide: 1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.
|
Control Group
n=4 Participants
This is the control group that will only ingest the capsule during video capsule endoscopy.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 5 • n=5 Participants
|
40 years
STANDARD_DEVIATION 5 • n=7 Participants
|
40 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: No data were collected from the enrolled participants. Study was terminated prior to collection of data.
Time for transit through small intestine.
Outcome measures
Outcome data not reported
Adverse Events
Oral Dissolving Metoclopramide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Friedel, MD
NYU Winthrop Hospital, Dep't of Gastroenterology
Phone: (516) 663-2528
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place