E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obesidad/Sobrepeso
Obesity/Overweight |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | 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 |
|
E.2.2 | Secondary objectives of the trial |
Evaluar la contribución relativa de determinados polimorfismos genéticos (serotoninérgicos y adrenérgicos) a la capacidad de ingesta de sujetos con sobrepeso u obesos sanos (basal y en respuesta a la manipulación farmacológica)
To evaluate the relative contribution of specific genetic polymorphisms (adrenergic and serotoninergic) on intake capacity in overweight/obese healthy subjects (basal and in response to pharmacological modulation) |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
o sujetos con sobrepeso u obesos (IMC>=25 Kg/m2) sanos o 18-65 años de edad
o overweight or obese (BMI>=25 Kg/m2) healthy subjects o 18-65 years of age |
|
E.4 | Principal exclusion criteria |
o Trastorno de la conducta alimentaria que se excluirá mediante el “Eating Attitude Test” o Enfermedades / condiciones orgánicas o funcionales que afectan el sistema gastrointestinal. El "Bowel Disease Questionnaire" se usará para excluir enfermos con el síndrome del intestino irritable. o Imposibilidad para cesar la toma de medicaciones durante las 48 horas previas a los estudios fisiológicos (Excepción: dosis estables de hormonas tiroideas, estrógenos, dosis cardioprotectoras de aspirina y pastillas / inyecciones depot anticonceptivas) o Mujeres embarazadas o en período de lactancia. o Evidencia clínica de diabetes, enfermedad significativa cardiovascular, respiratoria, renal, hepática, gastrointestinal, hematológica, neurológica, psiquiátrica u otras que puedan interferir con los objetivos de los estudios. o Hipersensibilidad conocida a la eritromicina o Incapacidad para dar consentimiento informado. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1-aceleración del vaciamiento gástrico (variable independiente modulada farmacológicamente) 2-ingesta calórica hasta hasta alcanzar la saciedad máxima (variable dependiente principal)
1-acceleration of gastric emptying rate (independent variable modulated through pharmacological means) 2-caloric intake to reach maximum satiation (principal dependent variable) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
coincide con la última visita
end of trial: last scheduled visit |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |