E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastroesophageal reflux disease |
Malattia da reflusso Gastroesofageo |
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E.1.1.1 | Medical condition in easily understood language |
Gastroesophageal reflux disease |
Malattia da reflusso Gastroesofageo |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018203 |
E.1.2 | Term | GERD |
E.1.2 | System Organ Class | 100000004856 |
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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 |
To evaluate the capacity of GERDOFF to improve higher symptoms in association with PPI (omeprazole) vs. the only treatment with PPI (omeprazole) during 6 weeks of treatment and during the following retention period of 12 weeks. |
Valutare la capacità di GERDOFF di migliorare la sintomatologia alta in associazione con PPI (omeprazolo) vs. il solo trattamento con PPI (omeprazolo) durante le 6 settimane di trattamento e durante il successivo periodo di mantenimento di 12 settimane. |
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E.2.2 | Secondary objectives of the trial |
To verify in treated patients: 1. number and percentage of Responders/Non-Responders at Visit V4, after 6 weeks of treatment with GERDOFF®+PPI/PPI; 2. number and percentage of patients maintaining the effect of treatment at FU Visit V6 vs. end of study visit V4 after 12 weeks of treatment with GERDOFF® or non-treatment (control group) ; 3. percentage of symptoms frequency reduction at V4, after 6 weeks of treatment, vs the baseline and vs the two groups of treatment; 4. percentage of symptoms frequency reduction at V6, after 18 weeks of treatment, vs V4 and vs. the two groups of treatments; 5. global patient satisfaction in respect of the treatment during the treatment period; 6. the potential concomitant utilization of other medication/products, not allowed, used as “rescue medication” during the first 6 weeks of treatment; 7. the potential concomitant use of “rescue medication”, permitted and not permitted, in the FU period. |
Verificare nei pazienti trattati: 1.Numero e percentuale di Responders /Non-Responders alla visita V4, dopo 6 settimane di trattamento con GERDOFF®+PPI/PPI; 2.Numero e percentuale di pazienti che mantengono l’effetto del trattamento alla visita di FU V6 vs la visita di fine studio V4, dopo 12 settimane di trattamento con GERDOFF o di non trattamento (gruppo controllo); 3.Percentuale di riduzione della frequenza dei sintomi alla V4, dopo 6 settimane di trattamento, vs il basale e vs i due gruppi di trattamento; 4.Percentuale di riduzione della frequenza dei sintomi alla V6, dopo 18 settimane di trattamento, vs V4 e vs i due gruppi di trattamento; 5.Soddisfazione complessiva del paziente verso il trattamento nel corso del periodo di trattamento; 6.Eventuale utilizzo concomitante di altri farmaci/prodotti, non ammessi, utilizzati come "rescue medication" nelle prime 6 settimane di trattamento; 7.Eventuale utilizzo concomitante di “rescue medication”, ammesse e non ammesse, nel FU. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subject; 2. age 18 years; 3. first diagnosis of GERD with higher symptoms, on clinical basis made and confirmed by ORL and/or confirmed by the Gastroenterologist through RSI Questionnaire; 4. presence of extraesophageal symptoms associated to GERD; 5. RSI value ≥ 20; 6. pazients not pre-treated with PPI, also for different problems from GERD, and/or medical devices and/orsimilar products (i.e. alginates) in the last 4 weeks. 7. cooperative patients, able to understand and respect study procedures; 8. patients able to freely provide their written informed consent to study participation; 9. patients who have freely given the consent to the treatment of study related personal data. |
1. soggetti maschi o femmine; 2. età 18 anni; 3. prima diagnosi di GERD con sintomi alti, posta su base clinica effettuata e confermata da ORL e/o confermata da Gastroenterologo mediante questionario RSI; 4. presenza di sintomatologia extra-esofagea associata alla GERD; 5. valore RSI ≥ 20; 6. pazienti non pretrattati con PPI, anche per problemi differenti dalla GERD, e/o con dispositivi medici, e/o con prodotti analoghi (es. alginati) nelle ultime 4 settimane. 7. pazienti collaboranti, in grado comprendere le procedure dello studio e di rispettarle; 8. pazienti in grado di dare liberamente il proprio consenso informato scritto di partecipazione allo studio; 9. pazienti che hanno dato liberamente il consenso al trattamento dati personali relativi allo studio.
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E.4 | Principal exclusion criteria |
1. known infective or alkaline or acid esophagitis; 2. acute or chronic rhinosinusitis; 3. chronic bronchitis; 4. known Zollinger-Ellison syndrome, hiatal hernia over 3 cm and Barrett esophagus; 5. ongoing neoplasy; 6. uncontrolled diabetes; 7. patients with impairment hepatic function; 8. patients with rare hereditary problems of galactose intolerance; 9. patients that, according to Investigator’s opinion, cannot be enrolled also due to other diseases or concomitant therapies like atazanavir, nelfinavir, clopidogrel, posaconazolo andd erlotinib (as recommended in the SPC); 10. patient with Lapp lactase deficiency; 11. patients with glucose-galactose malabsorption syndrom; 12. patients with hypersensitivity to omeprazole, to benzimidazolic substitutes or to any of the excipients; 13. patients already in treatment with PPI or similar products; 14. chronic use of medication interfering with salivary secretion (i.e. antistaminics or inhalated steroids); 15. drugs and alcohol abuse; 16. subject unable to adequately express his disorders; 17. patients with planned or established pregnancy or patients not adopting an accepted contraceptive method; 18. brest-feeding patients; 19. missing concession of personal data treatment consent. |
1. nota esofagite infettiva o da sostanze acide o alcaline; 2. rinosinusite acuta e cronica; 3. bronchite cronica; 4. nota sindrome di Zollinger-Ellison, ernia jatale superiore a 3 cm ed esofago di Barrett; 5. neoplasie in corso; 6. diabete non controllato; 7. pazienti con funzionalità epatica compromessa; 8. pazienti con rari problemi ereditari di intolleranza al galattosio; 9. pazienti che, a giudizio dello sperimentatore, non possono entrare nel protocollo anche in base ad altre patologie o terapie concomitanti quali ad esempio l’assunzione di atazanavir, nelfinavir, clopidogrel, posaconazolo ed erlotinib (come raccomandato in RCP); 10. pazienti con deficit di Lapp lattasi; 11. pazienti con sindrome da malassorbimento Glu-Gal; 12. pazienti con ipersensibilità ad omeprazolo, ai sostituti benzimidazolici o ad uno qualsiasi degli eccipienti; 13. pazienti già in trattamento con PPI o con prodotti analoghi; 14. uso cronico di farmaci che interferiscono con la secrezione salivare (es. antistaminici o steroidi per uso inalatorio); 15. abuso di droghe e alcol; 16. incapacità da parte del soggetto ad esprimere in modo adeguato i propri disturbi; 17. pazienti con pianificata o accertata gravidanza o che non adottano un metodo anticoncezionale accettato; 18. pazienti in allattamento; 19. mancata concessione del consenso al trattamento dei propri dati personali. |
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E.5 End points |
E.5.1 | Primary end point(s) |
At Visit V4 (end of the first phase of the study) it will be evaluated the difference in the respect of the baseline of the RSI questionnaire score to verify the effect of the treatment on higher symptoms. |
Alla visita V4 (fine prima fase dello studio) sarà valutata la variazione rispetto al basale nello score del questionario RSI per verificare l’effetto dei trattamenti sui sintomi alti. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
"Rescue medication" intake, when needed during the FU phase |
Il consumo di “rescue medication”, al bisogno nel corso della fase di FU |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the 18 weeks of study |
Nel corso delle 18 settimane di studio |
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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 | Yes |
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 | 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) | Yes |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Dispositivo Medico GERDOFF |
Medical Device GERDOFF |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 17 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 17 |
E.8.9.2 | In all countries concerned by the trial days | 0 |