Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia

NCT ID: NCT01724359

Last Updated: 2013-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone ER

Group Type: EXPERIMENTAL

Paliperidone ER

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag S.A. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag, S.A.

Locations

Buenos Aires, , Argentina

Rosario, , Argentina

Bogotá, , Colombia

Cali, , Colombia

Medellín, , Colombia

Countries

Argentina; Colombia

Other Identifiers

R076477SCH3029

Identifier Type: OTHER

Identifier Source: secondary_id

R076477SCH3036

Identifier Type: OTHER

Identifier Source: secondary_id

CR017413

Identifier Type: -

Identifier Source: org_study_id