E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
food intake and satiety |
voedselinname en verzadiging |
|
E.1.1.1 | Medical condition in easily understood language |
food intake and satiety |
voedselinname en verzadiging |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
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 |
To investigate the effect of intragastric infusion of lidocaine on ad libitum food intake |
Het effect van infusie van lidocaine in de maag op voedselinname |
|
E.2.2 | Secondary objectives of the trial |
1. To investigate the effect of intragastric infusion of lidocaine on satiety/satiation. 2. To study the effect of intragastric infusion of lidocaine on gastrointestinal complaints. |
1. Het effect van infusie van lidocaine in de maag op verzadiging. 2. Het effect van infusie van lidocaine in de maag op gastrointestinal symptomen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Based on medical history and previous examination, no gastrointestinal complaints can be defined. • Age between 18 and 50 years. Several studies (see introduction) showed a difference in response to a meal between young and elderly people. Inclusion of elderly could interfere with the outcome of this study. Goal of this study is to investigate whether a difference in food intake can be found after intragastric infusion of a local anaesthetic. For this proof of concept study we therefore choose to include healthy male volunteers with a maximum age of 50 years. This study will include healthy male subjects. • BMI between 20 and 25 kg/m2) • Weight stable over at least the last 6 months (≤5% weight change) |
- gezonde mannen in de leeftijd van 18-50 - gebaseerd op voorgeschiedenis en onderzoeken in het verleden, geen klachten van het maag-darm stelsel. - BMI tussen 20 en 25 kg/m2 - stabiel gewicht over de laatste 6 maanden (≤5% verandering in gewicht) |
|
E.4 | Principal exclusion criteria |
• Females, because of their hormonal cycle and the possible influence of these hormones on eating behaviour. • History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator. • Use of amiodaron, because of the cardiotoxicity (in combination with lidocaine). • Use of beta blockers, cimetidine and norepinephrine (synergetic effect on the action of Lidocaine). • Other use of medication, which could interfere with the outcome of the study. This will be decided by the principal investigator. • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 90 days prior to the study • Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator) • Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic) • Excessive alcohol consumption (>20 alcoholic consumptions per week) • Smoking • Self-admitted HIV-positive state • Any food allergy • Not able to eat a chili con carne meal. |
• Vrouwen, door de invloed van de hormonale cyclus op eetgedrag. • Voorgeschiedenis van ernstige cardiocasculaire, respiratoire, gastrointestinale/hepatische, haematologische, immunologische, KNO, dermatolosiche, bindweefsel, musculoskeletaal, metabool/voedings, endocrinologisch, neurologische of psychiatrische ziekten. Voorgeschiedenis van allergie, uitgebreide chirurgie of bloedonderzoeken die mogelijk een deelname in deze studie beperken. De ernst van de ziekte (grote van de invloed van de aandoening op de uitvoering van het experiment of voltooiing van het studieprotocol) zal bepaald worden door de hoofd onderzoeker. • gebruik van medicatie die zou kunnen interfereren met de uitkomsten van deze studie. Dit zal worden besloten door de hoofdonderzoeker • gebruik van een experimenteel medicijn of deelname in een ander wetenschappelijk onderzoek die mogelijk interfereert met de uitkomsten van dit onderzoek (wordt besloten door de hoofdonderzoeker) in de 90 dagen voorafgaand aan de start van dit onderzoek. - gebruik van amiodaron, omdat dit medicijn cardiologisch is in combinatie met lidocaine - gebruik van bètablokkers, cimetidine en norepinephrine (synergetisch effect op het werkingsmechanisme van lidocaine) • grote abdominale chirurgie en andere chirurgie beoordeeld door hoofdonderzoeker (ongecompliceerde appendectomie, cholecystectomie of hysterectomie uitgesloten) • dieet (medisch voorgeschreven, vegetarisch, diabeet, macrobiologisch, biologisch dynamisch). • actief alcohol misbruik (>20 eenheden per week). • roken • bloeddonatie 3 maanden voor de start van de studie • HIV positieve status, zelf aangegeven - voedselallergie - niet in staat om een chili con carne maaltijd op te eten
|
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E.5 End points |
E.5.1 | Primary end point(s) |
food intake in kcal |
voedselinname in kcal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after the ad libitum meal |
na de ad libitum maaltijd |
|
E.5.2 | Secondary end point(s) |
satiety/satiation (VAS scores) gastrointestinal symptoms (VAS scores) |
verzadiging (VAS scores) gastrointestinale symptomen (VAS scores) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
before during and after infusion of lidocaine and placebo |
voor tijdens en na infusie van lidocaine en de placebo |
|
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 | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.6 | Cross over | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
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 | 12 |
E.8.9.1 | In the Member State concerned days | 0 |