Clinical Trial Results:
Reducción de la Ingesta Calórica en la Obesidad Mediante Modulación Farmacológica del Vaciamiento Gástrico
Reduction of Caloric Intake in Obesity through Pharmacological Modulation of Gastric Emptying
Summary
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EudraCT number |
2004-004066-32 |
Trial protocol |
ES |
Global end of trial date |
30 Dec 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Nov 2021
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First version publication date |
06 Nov 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 |
OB/ERYTH 2004-004066-32
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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 |
VHIR
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Sponsor organisation address |
Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
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Public contact |
Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
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Scientific contact |
Silvia Delgado-Aros, VHIR, delgadoaross@gmail.com
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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 |
30 Dec 2010
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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 |
30 Dec 2010
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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 |
Evaluar si la aceleración del vaciamiento gástrico vía farmacológica puede inducir saciedad de forma precoz y, por tanto, reducir la ingesta calórica aguda en sujetos con sobrepeso u obesos sanos.
To evaluate if accelerating gastric emptying through pharmacological means may induce early satiety and thus, diminish caloric intake in overweight or obese healthy subjects
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Protection of trial subjects |
Participants were allowed to choose from three different Ensure flavors (chocolate, vanilla and strawberry) and were excluded from enrollment if they expressed a dislike for the taste of the test meal during the consent process.
We used the Hospital Anxiety and Depressions Scale to measure depression and anxiety scores.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2006
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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 |
Spain: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
30
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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 |
- | |||||||||
Pre-assignment
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Screening details |
We included overweight and obese (BMI>25Kgm-2) healthy subjects from the community, who were 18–65 years of age, with no gastrointestinal disease or symptoms. | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Erythomycin | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Erythromycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
60min infusion of intravenous erythromycin (3mg/Kg)
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Saline 0.9%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
60min infusion of intravenous saline
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Baseline characteristics reporting groups
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Reporting group title |
Erythomycin
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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 |
Erythomycin
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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 |
Acceleration gastric emptying | ||||||||||||
End point description |
Participants drank a nutrient liquid meal (Ensure Plus: 105Kcalml-1, 11% fat, 73% carbohydrate and 16% protein) at a constant rate (30mlmin-1.). Every 5min, participants scored their perception of fullness using a sixgrade scale that combines verbal descriptors and numbers (0=no sensation, 5=maximum fullness, I cannot eat more). Participants were asked to stop meal intake when they reached the score of 5.
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End point type |
Primary
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End point timeframe |
3o min after finishing drink test
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Statistical analysis title |
Gastric emptying | ||||||||||||
Comparison groups |
Placebo v Erythomycin
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
All the study (2 days)
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
14.1
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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 serious events were reported. Design of trial did not llow to collect other adverse effects |
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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. | |||
The effects of plasma hormones were not primary end points of the study. Administration of a prokinetic drug before meals might help to prevent weight gain, but currently there is unavailability of suitable agents | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/20938444 |