E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Heartburn and Erosive Esophagitis in Adolescent Subjects |
Bruciore di stomaco ed esofagite erosiva in soggetti adolescenti |
|
E.1.1.1 | Medical condition in easily understood language |
Heartburn and inflammation/swelling/irritation of the esophagus in Adolescent Subjects |
Bruciore di stomaco ed infiammazione / gonfiore / irritazione all 'esofago in soggetti adolescenti |
|
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018203 |
E.1.2 | Term | GERD |
E.1.2 | System Organ Class | 100000004856 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019326 |
E.1.2 | Term | Heartburn |
E.1.2 | System Organ Class | 100000004856 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063657 |
E.1.2 | Term | Erosive esophagitis |
E.1.2 | System Organ Class | 100000004856 |
|
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 assess the safety and effectiveness of treatment with once-daily oral administration of dexlansoprazole delayed release capsules 60 mg for 8 weeks in adolescent subjects, aged 12 to 17 years, with EE. To assess the safety and effectiveness of dexlansoprazole delayedrelease capsules 30 mg compared to matching placebo for 16 weeks in adolescent subjects for the maintenance of healed EE and relief of heartburn. |
Valutazione della sicurezza e dell’efficacia del trattamento con somministrazione orale quotidiana di dexlansoprazolo in capsule a rilascio ritardato da 60 mg per 8 settimane nei soggetti adolescenti di età compresa tra i 12 e i 17 anni affetti da EE. Valutazione della sicurezza e dell’efficacia di dexlansoprazolo in capsule a rilascio ritardato da 30 mg rispetto al placebo corrispondente per 16 settimane nei soggetti adolescenti per il mantenimento della EE cicatrizzata e il sollievo del bruciore di stomaco. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The subjects must be aged between 12 and 17 years, with a history of symptoms of gastroesophageal reflux disease (GERD) at least 3 months before screening, according to the investigator assessments. To be enrolled in the study, the subject must have heartburn for at least 3 days out of 7 during the screening as logging on daily electronic diary and endoscopically proven EE. |
I soggetti devono avere un’età compresa tra i 12 e i 17 anni, con un’anamnesi di sintomi da reflusso gastroesofageo (GERD) da almeno 3 mesi prima dello screening, in base alle valutazioni dello sperimentatore. Per essere arruolato nello studio, il soggetto deve presentare bruciori di stomaco per almeno 3 giorni su 7 durante il periodo di screening come da registrazione sul diario elettronico quotidiano ed EE comprovata endoscopicamente. |
|
E.4 | Principal exclusion criteria |
Subjects with an unusual or allergic reaction to dexlansoprazolo or any component of dexlansoprazolo, any of the other proton pump inhibitors (including lansoprazole, omeprazole, rabeprazole, esomeprazole, or pantoprazole), or with antacids containing magnesium hydroxide and / or hydroxide aluminum or simethicone. Individuals with evidence of cardiovascular disease, pulmonary, central nervous system, liver, hematopoietic, renal, metabolic, endocrine or gastrointestinal, or severe allergies, asthma or allergic skin rash that suggests the underlying disease or condition and uncontrolled clinically significant (different from the disease in study), which may affect the subject's ability to participate or could potentially confound the results of the study or any clinically significant discovery resulting from physical examinations and clinical laboratory results, in the opinion of the investigator. Those who need to take prescription drugs or over the counter, which are listed under Drugs & treatments except the Protocol (Section 7.3). |
Soggetti che presentano ipersensibilità o allergie al dexlansoprazolo o ad uno qualsiasi dei componenti del dexlansoprazolo, ad uno qualsiasi degli inibitori della pompa protonica (inclusi lansoprazolo, omeprazolo, rabeprazolo, esomeprazolo o pantoprazolo), o agli antiacidi contenenti idrossido di magnesio e/o idrossido di alluminio o al simeticone. Soggetti con evidenza di malattia cardiovascolare, polmonare, del sistema nervoso centrale, epatica, ematopoietica, renale, metabolica, endocrina o gastrointestinale, o grave allergia, asma o eruzione cutanea allergica che suggerisca patologia o condizione sottostante incontrollata e clinicamente significativa (diversa dalla malattia in studio), che possa influire sulla capacità del soggetto di partecipare o che possa confondere potenzialmente i risultati dello studio o qualsiasi scoperta clinicamente significativa derivante da esami obiettivi o risultati clinici di laboratorio, secondo il giudizio dello sperimentatore. Soggetti che necessitano di assumere farmaci su prescrizione o da banco, che sono elencati nel paragrafo Farmaci e trattamenti esclusi del Protocollo (Paragrafo 7.3). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Treatment-emergent adverse events experienced by ≥5% of subjects during the 8-week Treatment Period for healing of Erosive Esophagitis. 2. Treatment-emergent adverse events experienced by ≥5% of subjects during the 16-week double-blind Treatment Period for maintenance of healed Erosive Esophagitis. |
•Eventi avversi emergenti a seguito del trattamento (TEAE) vissuti da ≥5% dei soggetti nel corso del periodo di trattamento della durata di 8 settimane per la cicatrizzazione della EE. •TEAE vissuti da ≥5% dei soggetti nel corso del periodo di trattamento in doppio cieco della durata di 16 settimane per il mantenimento della EE cicatrizzata. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Ongoing over the first 8 weeks 2. Ongoing over the 24 week period. |
1. In corso nelle prime 8 settimane 2. In corso per tutto il periodo 24 settimane. |
|
E.5.2 | Secondary end point(s) |
1. The percentage of subjects with healing of Erosive Esophagitis by Week 8 as assessed by endoscopy.2. The percentage of subjects who maintain healing of Erosive Esophagitis from Week 8 to Week 24 among the subjects who were healed at Week 8 as assessed by endoscopy. 3. The percentage of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. 4. The percentage of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the subjects who were healed at Week 8. |
• Percentuale di soggetti con cicatrizzazione della EE dalla Settimana 8 come valutato mediante endoscopia. • Percentuale di soggetti che mantiene la cicatrizzazione della EE dalla Settimana 8 alla Settimana 24 tra i soggetti che risultano cicatrizzati alla Settimana 8 come valutato mediante endoscopia. • Percentuale di giorni senza bruciore di stomaco né durante le ore diurne né durante quelle notturne per le prime 8 settimane di trattamento, come da valutazione tratta dal diario elettronico giornaliero. • Percentuale di giorni senza bruciore di stomaco né durante le ore diurne né durante quelle notturne tra le settimane 8 e 24, come da valutazione tratta dal diario elettronico giornaliero tra i soggetti che risultavano cicatrizzati alla Settimana 8. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. By week 8 2. After 24 weeks 3. Over first 8 weeks 4. Over weeks 8 to 24 |
1. Dopo 8 settimane 2. Dopo 24 settimane 3. Oltre le prime 8 settimane 4. Oltre le settimana da 8 a 24 |
|
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 | Yes |
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) | 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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Una fase di guarigione in aperto seguita da una fase di manutenzione in doppio cieco |
An open label healing phase followed by a double blind maintenance |
|
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 | 3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Brazil |
Mexico |
United States |
|
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 | 15 |
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 | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |