E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obesity is classified as a body mass index (BMI) above 30 kg/m2 by the World Health Organization |
Obesità (definita dall’OMS da un indice di massa corporea-BMI > a 30 kg /m2 |
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E.1.1.1 | Medical condition in easily understood language |
Obesity is classified as a body mass index (BMI) above 30 kg/m2 by the World Health Organization |
Obesità (definita dall’OMS da un indice di massa corporea-BMI > a 30 kg /m2 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10070972 |
E.1.2 | Term | Gastroplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
The primary aim of this study is to evaluate the effect of PPI’s on the structural integrity of the ESG at 6 and 12 months, evaluated with upper endoscopy. At upper endoscopy the structural integrity of the ESG will be defined as: opened (all stiches loose), partially intact (at least one stich loose) or intact (all stiches tight). |
L’obiettivo primario è valutare l’efficacia degli IPP sulla porzione di pazienti con integrità della GVE a 6 e 12 mesi di follow-up. |
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E.2.2 | Secondary objectives of the trial |
Secondary aims are the effects of ESG on weight loss, quality of life, metabolic risk factors and anthropometry and on satiety. |
Valutare l’effetto degli IPP sui pazienti con “integrità parziale delle suture” e “apertura delle suture” separatamente a 6 e 12 mesi di follow-up. - Valutare l’effetto della GVE su: -istologia della mucosa gastrica tra i due gruppi (“ aperture delle suture” ed “integrità parziale delle suture”) a 0, 6 e 12 mesi; o perdita di peso; o aspetto dello stomaco alla gastroscopia; o qualità di vita; o fattori di rischio metaoblico (es. Profile lipidico) e misurazioni antropometriche (es. circonferenza del bacino e del torace); o antropometria; o effetto sulla sazietà; o composizione corporea; o reflusso gastroesofageo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 20 to 65 years - BMI between 30 to 45 kg/m2 - Willingness to participate in the study and ability to comply and understand the study protocol. |
- Età compresa tra 20 e 65 anni; - BMI compreso tra 30 e 45 kg/m2 - Capacità di comprendere il protocollo e firmare i consensi informati; |
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E.4 | Principal exclusion criteria |
- Active gastric gastro-duodenal during the last 6 months - Helicobacter pylori infection.- Organic or motility disorder of the stomach and / or esophagus - Anticoagulant treatment - Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum - Ongoing or active malignancy during the last 5 years. - Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association’s classification. - Drug or alcohol abuse - Bulimic or binge eating pattern - Continuous glucocorticoid or anti-inflammatory treatment - Uncontrolled thyroid disease. - Pregnancy, breastfeeding - Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study. - Hiatal hernia = 5 cm - Currently participating in other study - Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator. |
- Infezione gastrica o duodenale, da Helicobacter pylori nei 6 mesi precedenti; - Disturbi organici o della motilità dello stomaco e/o dell’esofago; - Trattamento con anticoagulanti; - Pregressa chirurgia bariatrica o qualsiasi tipo di chirurgia su esofago, stomaco e duodeno; - Neoplasie in atto o nel corso dei pregressi 5 anni;. - Infarto del miocardio nei 6 mesi pregressi o scompenso cardiac di tipo III o IV secondo la classificazione NHYA (New York Heart association’s classification); - Utilizzo di droghe e/o abuso di sostanze alcoliche; - Bulimia o binge eating; - Trattamento continuativo con glucocorticoidi o antiinfiammatori - Disturbi non controllati della tiroide; - Gravidanza, allattamento; - Condizioni psichiatriche, difficoltà nella cooperazione, scarsa aderenza alle istruzioni da seguire rappresentano delle controindicazioni per la partecipazione allo studio; - Ernia iatale = 5 cm - Partecipazione ad altri studi clinici in corso; - Qualsiasi disturbo che pone il paziente a rischio se il trattamento viene eseguito, a giudizio dell’investigatore. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end-point of the study is the assess the effect of PPIs on the proportion of patients with “Intact ESG” at 6 and 12 months of follow-up. |
L’obiettivo primario è valutare l’efficacia degli IPP sulla porzione di pazienti con integrità della GVE a 6 e 12 mesi di follow-up. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 and 12 months |
6 e 12 mesi |
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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 | No |
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 | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |