Clinical Trial Results:
Brain mechanisms underlying the effect of the motilin receptor agonist erythromycin on hunger in normal weight subjects
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Summary
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EudraCT number |
2013-004411-53 |
Trial protocol |
BE |
Global end of trial date |
16 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Feb 2021
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First version publication date |
18 Feb 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Erythromycin_v5
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UZLeuven / KULeuven / Targid
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
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Public contact |
Jan Tack, University of Leuven, 0032 1637 75 45, jan.tack@kuleuven.be
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Scientific contact |
Dongxing Zhao, University of Leuven, 0032 1637 75 45, dongxing.zhao@med.kuleuven.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Mar 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Mar 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Replicate the established effect of intravenous erythromycin infusion on hunger, and figure out the brain and/or hormonal mechanisms underlying the effect.
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Protection of trial subjects |
healthy women
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
14
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Right-handed, normal weight, healthy women (18–65 years) were included, to avoid sex as a potential confounder. | |||||||||
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Pre-assignment
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Screening details |
Exclusion criteria included smoking, substance abuse, regular intake of medications with an exception of oral contraception pills, chronic medical illness or illnesses affecting the gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric disorders, pregnancy and lactation, and any contraindication to MRI | |||||||||
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Period 1
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Period 1 title |
overall study period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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erythromycin | |||||||||
Arm description |
Cross over study with erythromycin and placebo. One hundred and fifteen minutes after breakfast, participants entered the MR scanner. After a 10 min adaptation period, the MRI scan started and lasted for 50 min in total. After 10 min baseline scanning, erythromycin [40 mg erythromycin lactobionate (Amdipharm Limited, Dublin, Ireland) dissolved in 100 mL 0.9% NaCl] were infused for 20 min (5 mL/min). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
erythromycin lactobionate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
40 mgerythromycin lactobionate (Amdipharm Limited, Dublin, Ireland) dissolved in 100 mL 0.9% NaCl] were infused for 20 min (5 mL/min).
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Arm title
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placebo | |||||||||
Arm description |
Cross over study with erythromycin and placebo. One hundred and fifteen minutes after breakfast, participants entered the MR scanner. After a 10 min adaptation period, the MRI scan started and lasted for 50 min in total. After 10 min baseline scanning, saline (100 mL 0.9% NaCl) was infused for 20 min (5 mL/min). | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
saline (0.9% NaCl)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
saline (100 mL 0.9% NaCl) was infused for 20 min (5 mL/min).
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Baseline characteristics reporting groups [1]
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Reporting group title |
overall study period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same. Justification: One volunteer was excluded from analysis after scanning because she concealed a medical history and current symptoms of functional dyspepsia. All analyses were performed on the remaining 13 volunteers. Also the baseline characteristics are described only for this 13 volunteers. |
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End points reporting groups
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Reporting group title |
erythromycin
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Reporting group description |
Cross over study with erythromycin and placebo. One hundred and fifteen minutes after breakfast, participants entered the MR scanner. After a 10 min adaptation period, the MRI scan started and lasted for 50 min in total. After 10 min baseline scanning, erythromycin [40 mg erythromycin lactobionate (Amdipharm Limited, Dublin, Ireland) dissolved in 100 mL 0.9% NaCl] were infused for 20 min (5 mL/min). | ||
Reporting group title |
placebo
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Reporting group description |
Cross over study with erythromycin and placebo. One hundred and fifteen minutes after breakfast, participants entered the MR scanner. After a 10 min adaptation period, the MRI scan started and lasted for 50 min in total. After 10 min baseline scanning, saline (100 mL 0.9% NaCl) was infused for 20 min (5 mL/min). | ||
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End point title |
change in hunger sensation | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
As hypothesized, the increase in hunger and prospective food consumption in the time period t = 30–40 min was significantly higher after erythromycin compared to placebo (planned contrast, lower tailed t-test, p = 0.023)
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| Notes [1] - cross over study [2] - cross over study |
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Statistical analysis title |
change in hunger | ||||||||||||
Comparison groups |
erythromycin v placebo
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Number of subjects included in analysis |
26
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.023 | ||||||||||||
Method |
lower tailed t-test | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit).
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
23
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: no adverse events occurred during this study |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/29379095 |
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