Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

SchizophreniaJNS007ERPositive and Negative Syndrome Scale (PANSS)PaliperidoneExtended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone

Outcome Measures

Primary Outcomes (1)

Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).
PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Baseline and 6 weeks

Secondary Outcomes (5)

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
Baseline and 6 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
Baseline and 6 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
Baseline and 6 weeks
Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])
Baseline and 6 weeks
Change From Baseline in Clinical Global Impression Scale (CGI-S)
Baseline and 6 weeks

Study Arms (3)

ER OROS paliperidone

EXPERIMENTAL

Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone

Drug: ER OROS paliperidone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Olanzapine

ACTIVE COMPARATOR

Drug: Olanzapine

Interventions

ER OROS paliperidoneDrug

Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.

ER OROS paliperidone

PlaceboDrug

Form= tablet, route= oral use. Two tablets once daily for 6 weeks.

Placebo

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who have given their own consent in writing to participate in the study
Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)

Sponsors & Collaborators

Janssen Pharmaceutical K.K.
Industrylead

Study Sites (56)

Aizu-Wakamatsu, Japan

Fujioka, Japan

Fujisawa, Japan

Fukui, Japan

Hadano, Japan

Himeji, Japan

Hiratsuka, Japan

Hiroshima, Japan

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Director of Clinical R&D Dept. 3
Organization: Janssen Pharmaceutical K.K.

Study Officials

Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

394 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 3, 2006

First Posted

November 7, 2006

Study Start

July 2006

Date type not reported

This date has not been verified as actual or estimated.

A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

ER OROS paliperidone

Placebo

Olanzapine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (56)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

ER OROS paliperidone

Placebo

Olanzapine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (56)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations