An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia

CompletadoFase 4ClinicalTrials.gov

ID: NCT01724359Tipo: INTERVENTIONALInicio: 1 de feb de 2008Fin estimado: 1 de nov de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.

Descripción detallada

This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patient meets the criteria for schizophrenia
Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
Patient is healthy on the basis of a physical examination and vital signs at screening
Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study

Criterios de exclusión

Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
Patients judged to be at high risk for adverse events, violence, or self-harm
Patients with known hypersensitivity to paliperidone ER or to risperidone
Patients with a current use or known history (over the past 6 months) of substance dependence

Intervenciones

drug

Paliperidone ER

The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.

Ubicaciones

Buenos Aires, Argentina

Rosario, Argentina

Patrocinadores

PrincipalJanssen-Cilag, S.A.

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

An Open-label Prospective Trial to Explore the Tolerabili... | EligiMed