Healthy VolunteersPhase 4NCT02212821
Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects
A Phase 4 study testing Erythromycin in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Erythromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Alcohol consumption > 7 drinks / week
- Major depression and chronic health conditions except controlled hypertension
About this study
The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.
- Conditions
- Healthy Volunteers
- Being tested
- Erythromycin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
PlaceboDrug
physiological saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | intravenous infusion Receives: Drug: Placebo |
| Erythromycin | Experimental | intravenous infusion Receives: Drug: Erythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain images
The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM.
Measured: 40 min after intervention
Secondary outcomes (2)
hunger scores
The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.
Measured: every 10 minutes since the scan starts
gut hormones
Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure gut hormones (motilin, ghrelin, CCK, PYY, GLP-1) by radioimmuno-assay.
Measured: every 10 min since the scan starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Principal investigator, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212821
- Sponsor's protocol ID
- Erythromycin_v6
- Status last verified
- Aug 2014
- First submitted
- 21 Mar 2014
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects
- ClinicalTrials.gov ID
- NCT02212821
- Acronym / sponsor ID
- Erythromycin_v6
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebointravenous infusion |
| Erythromycin | Experimental | Drug: Erythromycinintravenous infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Alcohol consumption > 7 drinks / week
- Major depression and chronic health conditions except controlled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythromycin | Drug | Erythromycin |
| Placebophysiological saline | Drug | Placebo |
Primary outcome
Functional brain images
Time frame: 40 min after intervention
The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM.
2 secondary outcomes
hunger scores
Time frame: every 10 minutes since the scan starts
gut hormones
Time frame: every 10 min since the scan starts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack principal investigator
University of Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythromycin in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional brain images (time frame: 40 min after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.