E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Gastroparesis |
Gastroparesi diabetica |
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E.1.1.1 | Medical condition in easily understood language |
Diabetic Gastroparesis |
Gastroparesi diabetica |
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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 | PT |
E.1.2 | Classification code | 10051153 |
E.1.2 | Term | Diabetic gastroparesis |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in this study (ie, after a total of 24 weeks of treatment¿12 weeks from lead-in study RLM-MD-01 or from lead-in study RLM-MD-02 and 12 weeks from the current study) in participants with DG with respect to the following core signs and symptoms of DG: nausea, abdominal pain, postprandial fullness, bloating.
To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in this study (ie, after a total of 24 weeks of treatment¿12 weeks from lead-in study RLM-MD-01 or from lead-in study RLM-MD-02 and 12 weeks from the current study) in participants with DG with respect to vomiting frequency
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Confrontare l'efficacia di relamorelin rispetto a placebo dopo 12 settimane di trattamento in questo studio (ovvero, dopo un totale di 24 settimane di trattamento: 12 settimane nello studio preliminare RLM-MD-01 o nello studio preliminare RLM-MD-02 e 12 settimane nel presente studio) in relazione ai seguenti segni e sintomi principali di GD: nausea, dolore addominale, pienezza postprandiale e gonfiore. Confrontare l'efficacia di relamorelin rispetto a placebo dopo 12 settimane di trattamento in questo studio (ovvero, dopo un totale di 24 settimane di trattamento: 12 settimane nello studio preliminare RLM-MD-01 o nello studio preliminare RLM-MD-02 e 12 settimane nel presente studio) in relazione alla frequenza del vomito. |
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E.2.2 | Secondary objectives of the trial |
- To compare the efficacy of relamorelin with placebo after 12 weeks of treatment in this study in participants with DG with respect to the following individual symptoms of the DGSSS: nausea, abdominal pain, postprandial fullness, bloating - To compare the efficacy of relamorelin with placebo after 40 weeks of treatment in this study in participants with DG with respect to the following core signs and symptoms of DG: nausea, abdominal pain, postprandial fullness, bloating - To compare the efficacy of relamorelin with placebo after 40 weeks of treatment in this study in participants with DG with respect to vomiting frequency - At the end of the 6-week randomized-withdrawal period (RWP), to demonstrate maintenance of efficacy among participants who were switched from relamorelin to placebo vs participants who continued relamorelin treatment To compare the safety of relamorelin with placebo in participants with DG
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- Confrontare, in partecipanti con GD, l'efficacia di relamorelin rispetto a placebo dopo 12 settimane di trattamento in questo studio in relazione ai soli sintomi del DGSSS elencati di seguito: nausea, dolore addominale, pienezza postprandiale e gonfiore. - Confrontare, in partecipanti con GD, l¿efficacia di relamorelin rispetto a placebo dopo 40 settimane di trattamento in questo studio in relazione ai seguenti segni e sintomi principali di GD: nausea, dolore addominale, pienezza postprandiale e gonfiore. - Confrontare, in partecipanti con GD, l'efficacia di relamorelin rispetto a placebo dopo 40 settimane di trattamento in questo studio in relazione alla frequenza del vomito. - Dimostrare il mantenimento dell'efficacia durante il Periodo di sospensione randomizzata (RWP) di 6 settimane tra i partecipanti che sono passati da relamorelin a placebo vs quelli che hanno continuato il trattamento con relamorelin - Confrontare la sicurezza di relamorelin vs placebo in partecipanti con GD |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 or Protocol RLM-MD-02 and successfully completed the study 2. Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures 3. In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02 |
1. Partecipante che soddisfaceva tutti i criteri di inclusione/esclusione del protocollo RLM-MD-01 o del protocollo RLM-MD-02 e ha completato con successo lo studio. 2. Soggetto in grado di fornire consenso informato scritto prima dell’esecuzione di qualsiasi procedura dello studio e disposto e in grado di attenersi alle procedure dello studio. 3. Partecipante che, a giudizio dello sperimentatore, abbia dimostrato adeguata compliance alle procedure dello studio nell’ambito di RLM-MD-01 o RLM-MD-02. |
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E.4 | Principal exclusion criteria |
1. Participant is not willing or able to abide by the restrictions regarding concomitant medicine use 2. Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03 3. Participant has an unresolved AE or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead ECG that, in the investigator’s opinion, would limit the participant’s ability to participate in or complete the study 4. Any other reason that, in the investigator’s opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease 5. Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, other study staff member, or employee of Allergan, Inc.; or the participant is a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or the participant is enrolled in this study at another clinical study site |
1. Partecipante non disposto o non in grado di rispettare le restrizioni relative all’uso di farmaci concomitanti. 2. Partecipante intenzionato a ricevere un farmaco sperimentale (diverso dal trattamento dello studio) o un dispositivo sperimentale in qualsiasi momento nel corso dello studio RLM-MD-03. 3. Partecipante con un EA non risolto o con un reperto clinicamente significativo all’esame obiettivo, nei test clinici di laboratorio o nell’ECG a 12 derivazioni che, a giudizio dello sperimentatore, ne limiterebbe la capacità di partecipare allo studio o di portarlo a termine. 4. Qualsiasi altro motivo, compresa un’eventuale patologia renale, epatica o cardiopolmonare che, a giudizio dello sperimentatore, potrebbe confondere la corretta interpretazione dello studio o esporre il partecipante a un rischio inaccettabile. 5. Soggetto direttamente o indirettamente coinvolto nella conduzione e nella gestione di questo studio in qualità di sperimentatore, co-sperimentatore, coordinatore dello studio, altro membro del personale dello studio o dipendente di Allergan, Inc.; oppure familiare di primo grado, partner o parente convivente con una delle suddette persone coinvolte direttamente o indirettamente nello studio; oppure partecipante arruolato in questo studio presso un altro centro. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Change from Baseline to Week 12 of this study in the weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) - Vomiting Week-12 Responder, defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-week Treatment Period |
- Modifica dal basale alla Settimana 12 dello studio nel punteggio di gravità dei sintomi della gastroparesi diabetica (DGSSS) settimanale. - Responder al vomito alla Settimana 12, definito come partecipante con episodi settimanali di vomito nulli durante ognuna delle ultime 6 settimane del primo periodo di trattamento di 12 settimane |
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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) |
- Individual Symptom (ie, nausea, abdominal pain, postprandial fullness, and bloating) Week-12 Responder - Change from Baseline (CFB) to Week 40 in the average weekly DGSSS - Vomiting Frequency at Week 40 - CFB to Week 40 in the average weekly number of vomiting episodes - CFB to end of RWP in the average weekly DGSSS - CFB to end of RWP in the number of vomiting episodes - AEs, clinical laboratory values, vital signs, electrocardiograms (ECGs), HbA1c, and anti-relamorelin antibodies |
- Responder ai singoli sintomi (nausea, dolore addominale, pienezza postprandiale e gonfiore) alla Settimana 12. - Variazione del DGSSS settimanale medio alla Settimana 40 rispetto al basale. - Frequenza del vomito alla Settimana 40. - Variazione del numero settimanale medio di episodi di vomito alla Settimana 40 rispetto al basale. - Variazione del DGSSS settimanale medio alla fine dell¿RWP rispetto al basale. - Variazione del numero di episodi di vomito alla fine dell¿RWP rispetto al basale. - EA, valori clinici di laboratorio, segni vitali, elettrocardiogrammi (ECG), emoglobina A1c (HbA1c) e anticorpi anti-relamorelin. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | 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 | 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.8.2.4 | 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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 231 |
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 | Information not present in EudraCT |
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 |
Argentina |
Australia |
Brazil |
Colombia |
India |
Israel |
Korea, Republic of |
Malaysia |
Mexico |
Philippines |
Russian Federation |
Saudi Arabia |
Singapore |
South Africa |
Thailand |
Ukraine |
United Arab Emirates |
Austria |
Belgium |
Bulgaria |
Denmark |
France |
Germany |
Hungary |
Italy |
Latvia |
Poland |
Romania |
Spain |
United Kingdom |
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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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The end of the study is defined as the date of the last visit of the last participant in the study. |
La conlusione della sperimentazione è definita come la data dell'ultima visita dell'ultimo paziente partecipante allo studio. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |