Clinical Trial Results:
The effect of mirtazapine (REMERGON®) on gastric motility and satiation in healthy subjects
Summary
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EudraCT number |
2014-004862-89 |
Trial protocol |
BE |
Global end of trial date |
23 Feb 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Feb 2021
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First version publication date |
14 Feb 2021
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Other versions |
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 |
mirtazapine1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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, UZLeuven / KULeuven / TARGID, 0032 16344225, jan.tack@kuleuven.be
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Scientific contact |
Florencia Carbone, UZLeuven / KULeuven / TARGID, 0032 16377535, florencia.carbone@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 |
22 Nov 2016
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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 |
23 Feb 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 |
The aim of the study is to investigate the mechanism of work of mitrazipine (Remergon) in gastric motility and sensivity, and satiation in healthy volunteers.
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Protection of trial subjects |
not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Feb 2015
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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: 31
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Worldwide total number of subjects |
31
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EEA total number of subjects |
31
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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) |
31
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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 |
Healthy volunteers had to be devoid of GI symptoms and of the use of medications known to influence gastrointestinal sensorimotor function. | ||||||||||||||||||
Pre-assignment
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Screening details |
Healthy volunteers, recruited by public advertisement | ||||||||||||||||||
Period 1
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Period 1 title |
overal 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 | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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mirtazapine | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
mirtazapine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Treatment consisted of a 3-week dosing of mirtazapine (15 mg) every night before sleeping for 3 weeks
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Arm title
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placebo | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Treatment consisted of a 3-week dosing of 1 placebo tablet every night before sleeping for 3 weeks
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Baseline characteristics reporting groups
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Reporting group title |
mirtazapine
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
mirtazapine
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Reporting group description |
- | ||
Reporting group title |
placebo
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Reporting group description |
- |
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End point title |
The effect of mirtazapine on intragastric volume after a meal | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
the effect of mirtazapine/placebo on gastric accommodation was measured with gastric barostat measurement at the end of a 3 week treatment with mirtazapine / placebo
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Statistical analysis title |
gastric accommodation after 3 week treatment | ||||||||||||
Statistical analysis description |
At baseline, the meal-induced
increase in intragastric balloon volume
(accommodation) was similar in both treatment groups (placebo:
271.49±42.67 mL and mirtazapine: 206.08±50.5 mL, P=.24). No differences
were observed after 3 weeks of treatment with placebo
(297.17±40.65 mL; P=.69). After 3 weeks of treatment
with mirtazapine, the intragastric barostat balloon volume was not significantly
altered (216.23±29.25 mL; P=.85).
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Comparison groups |
mirtazapine v placebo
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [1] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Notes [1] - In all analyses, P <.05 was considered statistically significant. No significant differences were found in the gastric accommodation. |
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Adverse events information
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23
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Reporting groups
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Reporting group title |
mirtazapine arm
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
placebo group
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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/28695632 |