E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Gastroparesis |
gastroparesia diabética |
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E.1.1.1 | Medical condition in easily understood language |
Diabetic Gastroparesis |
gastroparesia diabética |
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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 |
Comparar la eficacia de la relamorelina frente a la del placebo tras 12 semanas de tratamiento en este estudio (es decir, tras un total de 24 semanas de tratamiento: 12 semanas en el estudio inicial RLM-MD-01 o en el estudio inicial RLM-MD-02 y 12 semanas en el presente estudio) en participantes con gastroparesia diabética en cuanto a los siguientes signos y síntomas fundamentales de la enfermedad: Náuseas, Dolor abdominal, Plenitud posprandial, Meteorismo. Comparar la eficacia de la relamorelina frente a la del placebo tras 12 semanas de tratamiento en este estudio (es decir, tras un total de 24 semanas de tratamiento: 12 semanas en el estudio inicial RLM-MD-01 o en el estudio inicial RLM-MD-02 y 12 semanas en el presente estudio) en participantes con gastroparesia diabética en cuanto a la frecuencia de los vómitos. |
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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 |
Comparar la eficacia de la relamorelina frente a la del placebo tras 12 semanas de tratamiento en este estudio (es decir, tras un total de 24 semanas de tratamiento: 12 semanas en el estudio inicial RLM-MD-01 o en el estudio inicial RLM-MD-02 y 12 semanas en el presente estudio) en participantes con gastroparesia diabética (GD) en cuanto a los siguientes síntomas individuales de la DGSSS: Náuseas, Dolor abdominal, Plenitud posprandial, Meteorismo. -Comparar la eficacia de relamorelin frente a placebo después de 40 semanas de tratamiento en este estudio en pacientes con GD con síntomas individuales de la DGSSS: Náuseas, Dolor abdominal, Plenitud posprandial, Meteorismo. -Comparar la eficacia de la relamorelina con placebo después de 40 semanas de tratamiento en este estudio en participantes con GD con respecto a la frecuencia de vómitos Refierase al protocol para más objetivos secundarios. |
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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. Participantes que cumplieron todos los criterios de inclusión/exclusión del protocol RLM-MD-01 o del protocolo RLM-MD-02 y han completado de manera satisfactoria ese estudio 2. Con capacidad de otorgar su consentimiento informado por escrito antes de los procedimientos del estudio y con capacidad y voluntad de cumplir los procedimientos del estudio 3. Con adecuado cumplimiento de los procedimientos del estudio en el estudio RLM-MD-01 o RLM-MD-02, a juicio del investigador |
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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. Participante que no está dispuesto o no es capaz de atenerse a las restricciones relativas al uso de medicamentos concomitantes 2. Participante que tiene previsto recibir un fármaco en investigación (distinto del tratamiento del estudio) o un producto sanitario en investigación en algún momento a lo largo del estudio RLM-MD-03 3. Participante con un acontecimiento adverso no resuelto o un hallazgo de la exploración física, las pruebas de laboratorio o el ECG de 12 derivaciones, de importancia clínica, que a juicio del investigador limitaría la capacidad del participante para participar en el estudio o completarlo 4. Cualquier otro motivo que, a juicio del investigador, fuera a introducir un factor de confusión en la adecuada interpretación del estudio o expusiera al participante a un riesgo inaceptable, como enfermedades renales, hepáticas o cardiorrespiratorias 5. Participante que interviene directa o indirectamente en el desarrollo o la administración de este estudio como investigador, subinvestigador, coordinador del estudio, otro miembro del personal del estudio o empleado de Allergan, Inc.; o participante que es familiar en primer grado, pareja o pariente que reside con alguna de las personas mencionadas, intervinientes de forma directa o indirecta en el estudio; o participante que ha entrado en este estudio en otro centro del estudio clínico. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• The Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder • Vomiting Week-12 Responder |
Paciente con Respuesta (Responder) en cuanto a la Puntuación de la Intensidad de los Síntomas de Gastroparesia Diabética (Diabetic Gastroparesis Symptom Severity Score, DGSSS) en la Semana 12 Paciente con Respuesta en cuanto a los Vómitos en la Semana 12 |
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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 • DGSSS Week-40 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 |
Paciente con Respuesta en cuanto a los Síntomas Individuales (esto es, náuseas, dolor abdominal, plenitud posprandial y meteorismo) en la Semana 12. Paciente con Respuesta en cuanto a la DGSSS en la Semana 40 Variación respecto al valor Basal (Change from Baseline, CFB) del promedio semanal de la DGSSS en la Semana 40. Frecuencia de los vómitos en la Semana 40 Variación respecto al valor Basal del promedio semanal del número de episodios de vómitos en la Semana 40 Variación respecto al valor Basal del promedio semanal de la DGSSS al final del Periodo de Retirada Aleatorizada Variación respecto al valor Basal del número de episodios de vómitos al final del Periodo de Retirada Aleatorizada. Acontecimientos adversos (adverse event, AE), valores de laboratorio, constantes vitales, electrocardiogramas (ECG), HbA1c y anticuerpos antirrelamorelina |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 174 |
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 |
Argentina |
Australia |
Austria |
Belgium |
Brazil |
Bulgaria |
Colombia |
Denmark |
France |
Germany |
Hungary |
India |
Israel |
Italy |
Korea, Republic of |
Latvia |
Malaysia |
Mexico |
Philippines |
Poland |
Romania |
Russian Federation |
Saudi Arabia |
Singapore |
South Africa |
Spain |
Taiwan |
Thailand |
Ukraine |
United Arab Emirates |
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
|
The end of the study is defined as the date of the last visit of the last participant in the study. |
El fin de studio se define como la última visita del último paciente del estudio. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 10 |