A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia

NCT ID: NCT01606228

Last Updated: 2012-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.

Detailed Description

This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone ER; Treatment naive patients; Newly diagnosed patients

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

Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.

Interventions

Paliperidone ER

Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with schizophrenia
• Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
• Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
• Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
• Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study

Exclusion Criteria

• Serious unstable medical condition, including known clinically relevant laboratory abnormalities
• Judged to be at high risk for adverse events, violence or self-harm
• Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
• Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
• Patients with a current use or known history (over the past 6 months) of substance dependence
• Positive urine drug examination

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Jan-Cil Philippines

Principal Investigators

Janssen Pharmaceutica Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Other Identifiers

R076477SCH3033

Identifier Type: OTHER

Identifier Source: secondary_id

PAL-PHL-MA3

Identifier Type: OTHER

Identifier Source: secondary_id

CR014452

Identifier Type: -

Identifier Source: org_study_id