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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01379183
• Date of registration: 15/06/2011
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility
• Scientific title: Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small Bowel Motility
• Date of first enrolment: June 2011
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01379183
• Study type: Interventional
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Jeff Fidler, MD
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Normal healthy adult volunteers without known gastrointestinal disease

- Aged 18-70 years

- Able to provide written informed consent before participating in the study

- Able to communicate adequately with the investigator and to comply with the
requirements for the entire study.

Exclusion Criteria:

- Known allergy to erythromycin;

- Use of drugs that have known contraindication with erythromycin (concomitant therapy
with astemizole, cisapride, pimozide, or terfenadine)

- Corrected QT interval on EKG >460 msec

- Certain medications (i.e., theophylline, digoxin, oral anti-coagulant, benzodiazepine,
3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors) will either be
excluded from the study or, if medically safe, will be asked to discontinue the
medication for 4 half-lives before beginning the study.

- Use of medications that alter GI motility e.g., narcotics, medications with
significant anticholinergic effects

- Pregnant or breast-feeding females

- Known claustrophobia

- Known family history of sudden death or congenital QT prolongation

- Presence of pacemaker, internal defibrillator, or other non-MR compatible device

- Patients with known metal present within their abdomen



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Erythromycin

Other: Barium Sulfate Solution

Procedure: Magnetic Resonance Imaging

Drug: Placebo

Primary Outcome(s)

Gastric Volume [Time Frame: Approximately 60 minutes after beginning ingestion of fluid volume]

Secondary Outcome(s)

Small Intestine and Colon Volume [Time Frame: Approximately 60 minutes after beginning ingestion of fluid volume]

Ileal Volume [Time Frame: Approximately 60 minutes after beginning ingestion of fluid volume]

Colonic Volume [Time Frame: Approximately 60 minutes after beginning ingestion of fluid volume]

Jejunal Volume [Time Frame: Approximately 60 minutes after beginning ingestion of fluid volume]

Small Intestine Volume [Time Frame: Approximately 60 minutes after beginning ingestion of fluid volume]

Secondary ID(s)

10-004869

P01DK068055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Results

• Results available: Yes
• Date Posted: 27/01/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01379183