Clinical Trial Results:
The effect of acotiamide on gastric motility and satiation in healthy volunteers
Summary
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EudraCT number |
2014-002092-28 |
Trial protocol |
BE |
Global end of trial date |
27 Jul 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Feb 2021
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First version publication date |
26 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 |
acotiamide1
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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, KULeuven , 0032 16344225, jan.tack@kuleuven.be
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Scientific contact |
TARGID, KULeuven , 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 |
29 Jan 2018
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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 |
27 Jul 2017
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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 objective of this trial is to investigate the effect of acotiamide in gastric accommodation and satiation during and after meal
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Protection of trial subjects |
healthy volunteers
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Apr 2017
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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: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
20
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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 subjects aged between 18 and 60 years | |||||||||
Pre-assignment
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Screening details |
At inclusion, subjects did not show any gastrointestinal symptoms and were not taking any medication known to influence gastrointestinal sensorimotor function. | |||||||||
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 |
No
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Arm title
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acotiamide | |||||||||
Arm description |
acotiamide 100 mg, three times daily | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
acotiamide
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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 |
acotiamide 100 mg, three times daily, taken orally.
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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 |
placebo tablet, three times daily, taken orally.
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Baseline characteristics reporting groups
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Reporting group title |
overal study period
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Reporting group description |
cross over study design | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
acotiamide
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Reporting group description |
acotiamide 100 mg, three times daily | ||
Reporting group title |
placebo
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Reporting group description |
- |
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End point title |
gastric emptying rate | ||||||||||||
End point description |
subjects consumed a standardized solid meal consisting of one scrambled egg (of which the yolk
was labeled with 100 mg non‐radioactive (13C)‐octanoic acid), two slices of white bread and 150 mL of water within 10 minutes. Breath samples were collected before administration of the study drug (in duplo), and every 15 minutes
after the ingestion of the non‐radioactive (13C)‐octanoic acid for 4 hours by exhaling in an exetainer.
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End point type |
Primary
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End point timeframe |
Gastric emptying rate was assessed by a 13C‐octanoic acid breath test after 3 weeks treatment with acotiamide or placebo (cross over study design)
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Notes [1] - cross over study [2] - cross over study |
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Statistical analysis title |
gastric emptying rate | ||||||||||||
Comparison groups |
placebo v acotiamide
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.92 [3] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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Notes [3] - There was no difference in GE half time between both treatments (P = 0.92). |
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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 |
during acotiamide treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||
Reporting group title |
during placebo treatment
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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/30663175 |