Trial Outcomes & Findings for Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility (NCT NCT01379183)
NCT ID: NCT01379183
Last Updated: 2016-03-21
Results Overview
A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. MR images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet MRI. Gastric volumes were assessed with an axial 3D axial gradient echo sequence, which imaged the entire stomach in 13 seconds.
COMPLETED
PHASE2/PHASE3
40 participants
Approximately 60 minutes after beginning ingestion of fluid volume
2016-03-21
Participant Flow
Recruitment period: 07/09/2011 - 03/13/2013 Location: Mayo Clinic, Rochester, Minnesota
There was no wash out or run-in period following participant enrollment.
Participant milestones
| Measure |
Erythromycin
Erythromycin 200 mg i.v. suspension
|
Placebo
Matching placebo i.v. suspension
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility
Baseline characteristics by cohort
| Measure |
Erythromycin
n=19 Participants
Erythromycin 200 mg i.v. suspension
|
Placebo
n=21 Participants
Matching placebo i.v. suspension
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
35 years
STANDARD_DEVIATION 13 • n=107 Participants
|
35 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
21 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volumeA Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. MR images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet MRI. Gastric volumes were assessed with an axial 3D axial gradient echo sequence, which imaged the entire stomach in 13 seconds.
Outcome measures
| Measure |
Erythromycin
n=19 Participants
Erythromycin 200 mg i.v. suspension
|
Placebo
n=21 Participants
Matching placebo i.v. suspension
|
|---|---|---|
|
Gastric Volume
|
262 mL
Standard Error 52
|
718 mL
Standard Error 59
|
SECONDARY outcome
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volumeThe jejunum is the section of the small intestine between the duodenum and the ileum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Outcome measures
| Measure |
Erythromycin
n=19 Participants
Erythromycin 200 mg i.v. suspension
|
Placebo
n=21 Participants
Matching placebo i.v. suspension
|
|---|---|---|
|
Jejunal Volume
|
450 mL
Standard Error 74
|
359 mL
Standard Error 43
|
SECONDARY outcome
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volumeThe Ileal is the terminal portion of the small intestine extending from the jejunum to the cecum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Outcome measures
| Measure |
Erythromycin
n=19 Participants
Erythromycin 200 mg i.v. suspension
|
Placebo
n=21 Participants
Matching placebo i.v. suspension
|
|---|---|---|
|
Ileal Volume
|
248 mL
Standard Error 30
|
248 mL
Standard Error 27
|
SECONDARY outcome
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volumeA Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Outcome measures
| Measure |
Erythromycin
n=19 Participants
Erythromycin 200 mg i.v. suspension
|
Placebo
n=21 Participants
Matching placebo i.v. suspension
|
|---|---|---|
|
Colonic Volume
|
190 mL
Standard Error 53
|
180 mL
Standard Error 36
|
SECONDARY outcome
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volumeA Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Outcome measures
| Measure |
Erythromycin
n=19 Participants
Erythromycin 200 mg i.v. suspension
|
Placebo
n=21 Participants
Matching placebo i.v. suspension
|
|---|---|---|
|
Small Intestine Volume
|
698 mL
Standard Error 99
|
607 mL
Standard Error 56
|
SECONDARY outcome
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volumeA Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.
Outcome measures
| Measure |
Erythromycin
n=19 Participants
Erythromycin 200 mg i.v. suspension
|
Placebo
n=21 Participants
Matching placebo i.v. suspension
|
|---|---|---|
|
Small Intestine and Colon Volume
|
910 mL
Standard Error 66
|
781 mL
Standard Error 65
|
Adverse Events
Erythromycin
Placebo
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