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Trial record 22 of 180 for:    ERYTHROMYCIN

Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility

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ClinicalTrials.gov Identifier: NCT01379183
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : January 27, 2014
Last Update Posted : March 21, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jeff Fidler, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition Healthy
Interventions Drug: Erythromycin
Drug: Placebo
Procedure: Magnetic Resonance Imaging
Other: Barium Sulfate Solution
Enrollment 40
Recruitment Details Recruitment period: 07/09/2011 - 03/13/2013 Location: Mayo Clinic, Rochester, Minnesota
Pre-assignment Details There was no wash out or run-in period following participant enrollment.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description Erythromycin 200 mg i.v. suspension Matching placebo i.v. suspension
Period Title: Overall Study
Started 19 21
Completed 19 21
Not Completed 0 0
Arm/Group Title Erythromycin Placebo Total
Hide Arm/Group Description Erythromycin 200 mg i.v. suspension Matching placebo i.v. suspension Total of all reporting groups
Overall Number of Baseline Participants 19 21 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 21 participants 40 participants
34  (12.6) 35  (13) 35  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Female
12
  63.2%
12
  57.1%
24
  60.0%
Male
7
  36.8%
9
  42.9%
16
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 21 participants 40 participants
19 21 40
1.Primary Outcome
Title Gastric Volume
Hide Description 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.
Time Frame Approximately 60 minutes after beginning ingestion of fluid volume
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
Erythromycin 200 mg i.v. suspension
Matching placebo i.v. suspension
Overall Number of Participants Analyzed 19 21
Mean (Standard Error)
Unit of Measure: mL
262  (52) 718  (59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Jejunal Volume
Hide Description The 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.
Time Frame Approximately 60 minutes after beginning ingestion of fluid volume
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:

Erythromycin 200 mg i.v. suspension

Erythromycin: 200 mg suspension

Matching placebo i.v. suspension

Placebo: 200 mg suspension

Overall Number of Participants Analyzed 19 21
Mean (Standard Error)
Unit of Measure: mL
450  (74) 359  (43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Ileal Volume
Hide Description The 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.
Time Frame Approximately 60 minutes after beginning ingestion of fluid volume
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:

Erythromycin 200 mg i.v. suspension

Erythromycin: 200 mg suspension

Matching placebo i.v. suspension

Placebo: 200 mg suspension

Overall Number of Participants Analyzed 19 21
Mean (Standard Error)
Unit of Measure: mL
248  (30) 248  (27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Colonic Volume
Hide Description 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.
Time Frame Approximately 60 minutes after beginning ingestion of fluid volume
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:

Erythromycin 200 mg i.v. suspension

Erythromycin: 200 mg suspension

Matching placebo i.v. suspension

Placebo: 200 mg suspension

Overall Number of Participants Analyzed 19 21
Mean (Standard Error)
Unit of Measure: mL
190  (53) 180  (36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Small Intestine Volume
Hide Description 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.
Time Frame Approximately 60 minutes after beginning ingestion of fluid volume
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:

Erythromycin 200 mg i.v. suspension

Erythromycin: 200 mg suspension

Matching placebo i.v. suspension

Placebo: 200 mg suspension

Overall Number of Participants Analyzed 19 21
Mean (Standard Error)
Unit of Measure: mL
698  (99) 607  (56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Small Intestine and Colon Volume
Hide Description 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.
Time Frame Approximately 60 minutes after beginning ingestion of fluid volume
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:

Erythromycin 200 mg i.v. suspension

Erythromycin: 200 mg suspension

Matching placebo i.v. suspension

Placebo: 200 mg suspension

Overall Number of Participants Analyzed 19 21
Mean (Standard Error)
Unit of Measure: mL
910  (66) 781  (65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description Erythromycin 200 mg i.v. suspension Matching placebo i.v. suspension
All-Cause Mortality
Erythromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erythromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erythromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jeff L. Fidler
Organization: Mayo Clinic
Phone: 507-284-5010
EMail: fidler.jeff@mayo.edu
Layout table for additonal information
Responsible Party: Jeff Fidler, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01379183     History of Changes
Other Study ID Numbers: 10-004869
P01DK068055 ( U.S. NIH Grant/Contract )
First Submitted: June 15, 2011
First Posted: June 23, 2011
Results First Submitted: December 11, 2013
Results First Posted: January 27, 2014
Last Update Posted: March 21, 2016