Trial Outcomes & Findings for Study of Metoclopramide in Small Bowel Capsule Endoscopy (NCT NCT01630109)

Results Overview

This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

12 hours

Results posted on

2014-02-27

Participant Flow

Study subjects were recruited from December 2012 to June 2013. The subjects were recruited in the Medical Procedures Unit at Genesys Regional Medical Center.

No events to report.

Participant milestones

Participant milestones
Measure	Metoclopramide 5 mg Pro-motility agent	Metoclopramide 10 mg Pro-motility agent	Placebo Control Placebo to be used as the control group
Overall Study STARTED	1	1	3
Overall Study COMPLETED	1	1	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Metoclopramide in Small Bowel Capsule Endoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metoclopramide 5 mg n=1 Participants Pro-motility agent	Metoclopramide 10 mg n=1 Participants Pro-motility agent	Placebo Control n=3 Participants Placebo to be used as the control group	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	54 years STANDARD_DEVIATION 0 • n=5 Participants	59 years STANDARD_DEVIATION 0 • n=7 Participants	46 years STANDARD_DEVIATION 12.76 • n=5 Participants	50.20 years STANDARD_DEVIATION 10.84 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 hours

This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).

Outcome measures

Outcome measures
Measure	Metoclopramide 5 mg n=1 Participants Pro-motility agent	Metoclopramide 10 mg n=1 Participants Pro-motility agent	Placebo Control n=3 Participants Placebo to be used as the control group	Metoclopramide 5 mg (Non-diabetic) Pro-motility agent given to non-diabetic patients	Metoclopramide 10 mg (Non-diabetic) Pro-motility agent given to non-diabetic patients	Placebo (Non-diabetic) Placebo control given to non-diabetics
Difference in Treatment vs. Placebo in Pill Capsule Completion Rates	100 percentage of complete capsule studies	0 percentage of complete capsule studies	100 percentage of complete capsule studies	—	—	—

SECONDARY outcome

Timeframe: 12 hours

This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.

Outcome measures

Outcome measures
Measure	Metoclopramide 5 mg n=1 Participants Pro-motility agent	Metoclopramide 10 mg n=1 Participants Pro-motility agent	Placebo Control n=3 Participants Placebo to be used as the control group	Metoclopramide 5 mg (Non-diabetic) Pro-motility agent given to non-diabetic patients	Metoclopramide 10 mg (Non-diabetic) Pro-motility agent given to non-diabetic patients	Placebo (Non-diabetic) Placebo control given to non-diabetics
Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies	15 minutes Standard Deviation 0	57 minutes Standard Deviation 0	88 minutes Standard Deviation 106.12	—	—	—

SECONDARY outcome

Timeframe: 12 hours

This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo.

Outcome measures

Outcome measures
Measure	Metoclopramide 5 mg n=1 Participants Pro-motility agent	Metoclopramide 10 mg n=1 Participants Pro-motility agent	Placebo Control n=3 Participants Placebo to be used as the control group	Metoclopramide 5 mg (Non-diabetic) Pro-motility agent given to non-diabetic patients	Metoclopramide 10 mg (Non-diabetic) Pro-motility agent given to non-diabetic patients	Placebo (Non-diabetic) Placebo control given to non-diabetics
Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies	53 minutes Standard Deviation 0	218 minutes Standard Deviation 0	301 minutes Standard Deviation 114.45	—	—	—

SECONDARY outcome

Timeframe: 12 hours

This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic.

Outcome measures

Outcome measures
Measure	Metoclopramide 5 mg Pro-motility agent	Metoclopramide 10 mg Pro-motility agent	Placebo Control n=1 Participants Placebo to be used as the control group	Metoclopramide 5 mg (Non-diabetic) n=1 Participants Pro-motility agent given to non-diabetic patients	Metoclopramide 10 mg (Non-diabetic) n=1 Participants Pro-motility agent given to non-diabetic patients	Placebo (Non-diabetic) n=2 Participants Placebo control given to non-diabetics
Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics	—	—	100 Percentage of complete studies	100 Percentage of complete studies	0 Percentage of complete studies	100 Percentage of complete studies

Adverse Events

Metoclopramide 5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoclopramide 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control

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

Dr. Steven Brooks

Genesys Regional Medical Center Office of Research

Phone: 8106067722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place