E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy |
estreñimiento inducido por opiáceos en pacientes con dolor crónico de origen no oncológico que están recibiendo tratamiento con opiáceos |
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E.1.1.1 | Medical condition in easily understood language |
Opioid-induced Constipation |
estreñimiento inducido por opiáceos |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071128 |
E.1.2 | Term | Opioid induced constipation |
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 long-term safety of naldemedine for the treatment of constipation due to opioid therapy |
evaluar la seguridad a largo plazo de la naldemedina en el tratamiento del estreñimiento inducido por opiáceos |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the overall safety and tolerability of naldemedine |
- Evaluar la seguridad y la tolerabilidad globales de la naldemedina. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects aged 18 to 80 years inclusive at the time of informed consent - Subjects must have non-malignant chronic pain and must have OIC - Subjects must be treated with a stable opioid regimen at a total daily dose on average of ? 30 mg equivalents of oral morphine sulfate - Subjects may or may not be on a routine laxative regimen at the time of Screening |
- Pacientes con edades comprendidas entre 18 y 80 años hasta el momento del consentimiento informado. - Los pacientes deben padecer dolor crónico de origen no oncológico además de EIO. - Los pacientes deben estar en tratamiento estable con opiáceos, con una dosis diaria total media ? 30 mg de equivalentes al sulfato de morfina, - En el momento del screening, los pacientes podrán estar o no en tratamiento laxante de rutina |
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E.4 | Principal exclusion criteria |
- Evidence of significant structural abnormalities of the gastrointestinal (GI) tract a. history of bowel obstructions, strictures b. history of bowel surgery such as bowel resection or bariatric surgeries - Evidence of active medical diseases affecting bowel transit - History of pelvic disorders that may be a cause of constipation - Surgery (except for minor procedures) within 60 days of Screening - History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical gastrointestinal obstruction) - Subjects who have never taken laxatives for the treatment of OIC - Current use of any prohibited medication including opioid antagonists, partial agonists or mixed opioid agonists/antagonists |
- Hechos indicativos de anomalías estructurales importantes del tubo digestivo (TD). a. antecedentes de obstrucción o estenosis intestinales b. antecedentes de intervención quirúrgica intestinal, como enterectomía o cirugía bariátrica - Pruebas de enfermedades activas que afecten al tránsito intestinal - Antecedentes de alteraciones pélvicas que puedan ser las causantes del estreñimiento. - Haber sido sometido a una intervención quirúrgica (excepto las intervenciones menores) en los 60 días previos al screening - Antecedentes de estreñimiento crónico antes del comienzo del tratamiento farmacológico analgésico o cualquier posible causa de enteropatía que no se deba a los opiáceos y que pudiera ser una causa principal del estreñimiento (p. ej., obstrucción intestinal mecánica). - Pacientes que nunca hayan tomado laxantes para el tratamiento del EIO. - El uso actual de cualquier medicamento prohibido , que incluye, entre otros, antagonistas, agonistas parciales o agonistas-antagonistas combinados opiáceos. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary safety endpoint is the number of Major Adverse Cardiac Events (MACE) during a 52-week Treatment Period |
El criterio de valoración principal de la seguridad es el número de acontecimientos adversos cardiovasculares graves (AACVG) que se produzcan durante el período de tratamiento de 52 semanas. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
To evaluate the overall safety and tolerability of naldemedine |
Evaluar la seguridad y la tolerabilidad globales de la naldemedina. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
WK 52 |
Semana 12 y semana 52 |
|
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) | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 118 |
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 |
Belgium |
Canada |
Denmark |
France |
Italy |
Austria |
Netherlands |
Portugal |
Sweden |
Australia |
Czech Republic |
Estonia |
Germany |
Hungary |
Spain |
Israel |
Poland |
South Africa |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
Last Visit Last Subject (LVLS) |
Ultima visita del último paciente. |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |