NCT02212821

Brief Summary

The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4 healthy-volunteers

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

November 30, 2016

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

March 21, 2014

Last Update Submit

November 29, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Functional brain images

    The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM.

    40 min after intervention

Secondary Outcomes (2)

  • hunger scores

    every 10 minutes since the scan starts

  • gut hormones

    every 10 min since the scan starts

Study Arms (2)

Placebo

PLACEBO COMPARATOR

intravenous infusion

Drug: Placebo

Erythromycin

EXPERIMENTAL

intravenous infusion

Drug: Erythromycin

Interventions

ErythromycinDRUG
Erythromycin
PlaceboDRUG

physiological saline

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female only.
  • Age \> 18 and \< 60.
  • Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5 kg in the past three months).
  • Not known to have any chronic medical illness or illnesses affecting the gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric disorder.
  • If female not known to be pregnant.
  • Not known to have any past upper gastrointestinal surgery.

You may not qualify if:

  • Alcohol consumption \> 7 drinks / week
  • Major depression and chronic health conditions except controlled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Erythromycin

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Jan Tack

    University of Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

August 8, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Last Updated

November 30, 2016

Record last verified: 2014-08