E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia |
Esquizofrenia |
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E.1.1.1 | Medical condition in easily understood language |
Schizophrenia |
Esquizofrenia |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
E.1.2 | System Organ Class | 10037175 - Psychiatric 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 investigate the long-term safety and tolerability of flexible doses of bifeprunox, compared to flexible doses of risperidone, over a 6 months treatment period, in patients with schizophrenia, having completed study 10199. |
Investigar la seguridad y tolerabilidad a largo plazo de dosis flexibles de bifeprunox en comparación con dosis flexibles de risperidona, durante un periodo de tratamiento de 6 meses en pacientes con esquizofrenia, que hayan completado el ensayo 10199 |
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E.2.2 | Secondary objectives of the trial |
To investigate the long-term efficacy of bifeprunox, compared to flexible doses of risperidone, over a 6 months treatment period, in patients with schizophrenia, having completed study 10199. |
Investigar la eficacia a largo plazo de bifeprunox en comparación con dosis flexibles de risperidona, durante un periodo de tratamiento de 6 meses en pacientes con esquizofrenia, que hayan completado el ensayo 10199. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title:A pharmacoeconomic study conducted in parallel with clinical trial 10200, a 24-week double-blind, risperidone-referenced, flexible dose, parallel-group extension study of bifeprunox in patients with schizophrenia Version and date: Final, 30 July 2003 Objective:To evaluate and compare the costs and patient-reported outcomes (PRO) of 24-week treatment with either bifeprunox or risperidone in patients with schizophrenia, having completed the pharmacoeconomic study 10224 |
Título: Estudio de farmacoeconomía desarrollado en paralelo al ensayo clínico 10200, un estudio de extensión de 6 meses con bifeprunox, doble ciego, con risperidona como fármaco de referencia, dosis flexible, con grupos paralelos, en pacientes con esquizofrenia Versión y fecha: Final, 30 julio 2003 Objetivo: Evaluar y comparar los costes y los resultados en salud referidos por el paciente del tratamiento durante 6 meses con bifeprunox o risperidona en pacientes con esquizofrenia, que hayan finalizado el estudio de farmacoeconomía 10224 |
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E.3 | Principal inclusion criteria |
1. The patient or patient?s authorized legal representative must understand the nature of the study and must have given written informed consent. 2. The patient must have completed study 10199 immediately prior to enrolment into the extension study. 3. On the basis of a physical examination, medical history, electrocardiogram, blood biochemistry, haematology tests and a urinalysis carried out at the Termination Visit of study 10199, the patient is, in the investigator?s opinion, otherwise healthy. 4. A female patient of child-bearing potential may be enrolled provided that she: b. has a negative pregnancy test (blood serum beta-HCG) prior to Visit 1 (= Termination Visit of study 10199), and c. is routinely using one of the following medically acceptable methods of birth control: i. oral contraception at a stable dose for at least 3 months prior to entry into the study ii. the first dose of medroxyprogesterone or other i.m. injection administered at least 2 months prior to entry into the study, and has been maintaining the recommended administration schedule. iii. implementation of levonorgestrel system or an inta-uterine device for at least 2 months prior to entry into the study iv. barrier methods (combination of diaphragm and spermicidal or condom and spermicide) prior to and during the trial, and c. is not breast feeding, and d. agrees not to become pregnant during the trial |
1. El paciente o el representante legal del paciente debe comprender la naturaleza del ensayo y debe haber dado su consentimiento informado por escrito. 2. El paciente debe haber finalizado el ensayo 10199 inmediatamente antes de ser incluido en el estudio de extensión. 3. Pacientes con un buen estado de salud, en opinión del investigador, basándose en la exploración física, el historial médico, el electrocardiograma, los análisis de sangre bioquímico y hematológico y el análisis de orina realizados en la Visita de Finalización del ensayo 10199. 4. Una mujer con potencial para quedar embarazada podría ser incluida en el estudio siempre que: a. tenga un test de embarazo negativo (suero sanguíneo beta-HCG) previo a la Visita 1 (= Visita de Finalización del ensayo 10199), y b. esté utilizando de forma habitual uno de los siguientes métodos para el control de la natalidad aceptados médicamente: i. contracepción oral a dosis estables durante al menos los 3 meses previos a la inclusión en el ensayo ii. la primera dosis de medroxiprogesterona u otra inyección i.m. administrada al menos en los 2 meses previos a la inclusión en el ensayo, y que se haya mantenido el calendario recomendado de administración iii. implementación del sistema levonorgestrel o un dispositivo intrauterino en al menos los 2 meses previos a la inclusión en el ensayo iv. métodos de barrera (combinación de diafragma y espermicida o preservativo y espermicida) antes y durante el ensayo, y c.no esté en periodo de lactancia, y d.esté de acuerdo en no quedarse embarazada durante el ensayo |
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E.4 | Principal exclusion criteria |
Patients meeting any of the exclusion criteria applying for patients at entry to study 10199, except for exclusion criteria 19 (hospitalisation for the current episode for more than four weeks), 23 (need for continuous treatment with anticholinergic drugs), 24 (exposure to any investigational drug within 60 days prior to study entry), and 26 (prior exposure to bifeprunox), cannot be included in the study |
No pueden ser incluidos en el ensayo los pacientes que cumplan algún criterio de exclusión requerido para el ensayo 10199, excepto para el criterio de exclusión 19 (hospitalización por el episodio psicótico actual durante más de cuatro semanas), 23 (necesidad de tratamiento continuo con fármacos anticolinérgicos), 24 (exposición a un fármaco en investigación 60 días previos a la Visita Basal) y 26 (exposición previa a bifeprunox) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be the change from Baseline of the PANSS total score. Secondary efficacy measurements include the positive symptom sub-scale score of PANSS, the negative symptom sub-scale score of PANSS, the general psychopathology sub-scale of the PANSS, Clinical Global Impression-Severity (CGI-S), CGI-Improvement (CGI-I), Calgary Depression Scale for Schizophrenia (CDSS), relapse rates and responder rates |
La variable principal de eficacia será el cambio en la puntuación total de la PANSS desde la Visita Basal. Las evaluaciones secundarias de eficacia incluyen la puntuación de la subescala de síntomas positivos de la PANSS, la puntuación de la subescala de síntomas negativos de la PANSS, la puntuación de la subescala de psicopatología general de la PANSS, la Impresión Clínica Global de Gravedad (CGI-S), la Impresión Clínica Global de Mejoría (CGI-I), la Escala de Depresión de Calgary para la Esquizofrenia (CDSS), las tasas de recaída y las tasas de respondedores |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Visit 1 2 3 4 5 6 Termination Visit1 (TV) Follow-up visit Month 0 1 2 3 4 5 6 or withdrawal 1 week after TV Day 1 31 61 91 121 151 181 188 |
Visita nº 1 2 3 4 5 6 Visita de Finalización1 (VF) Visita de Seguimiento Mes 0 1 2 3 4 5 6 ó retirada 1 semana después de VF Día 1 31 61 91 121 151 181 188 |
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E.5.2 | Secondary end point(s) |
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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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 |
Germany |
Greece |
Hong Kong |
Malaysia |
Netherlands |
Philippines |
Spain |
Sweden |
Thailand |
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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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? safety concerns ? proven lack of efficacy from other completed studies ? the investigator does not comply with the protocol, Good Clinical Practice, and/or any contract between the investigator and H. Lundbeck A/S, including affiliates and subsidiaries hereof |
? Preocupaciones relativas a la seguridad ? Demostración de la falta de eficacia del fármaco en investigación, mediante otros ensayos clínicos finalizados ? El investigador no cumple con el protocolo, las directrices de Buena Práctica Clínica y/o cualquier contrato suscrito entre el investigador y H. Lundbeck A/S, incluyendo sus afiliados y subsidiarias |
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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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |