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

NCT ID: NCT00396565

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2007-11-30

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

Detailed Description

This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ER OROS paliperidone

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

Group Type: EXPERIMENTAL

ER OROS paliperidone

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Olanzapine

Group Type: ACTIVE_COMPARATOR

Olanzapine

Intervention Type: DRUG

Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.

Interventions

ER OROS paliperidone

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Olanzapine

Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)
• Patients who have acute symptoms of schizophrenia
• Both inpatients and outpatients are acceptable

Exclusion Criteria

• A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
• A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
• Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120
• Patients treated with three or more types of antipsychotic within 28 days before the screening test
• Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
• Patients with a complication of or a past history of cerebrovascular accident
• Patients with a complication of or a past history of diabetes mellitus

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Aizu-Wakamatsu, , Japan

Fujioka, , Japan

Fujisawa, , Japan

Fukui, , Japan

Hadano, , Japan

Himeji, , Japan

Hiratsuka, , Japan

Hiroshima, , Japan

Ibaraki, , Japan

Ichikawa, , Japan

Iida, , Japan

Inazawa, , Japan

Itoman, , Japan

Kaizuka, , Japan

Kanzaki, , Japan

Kashihara, , Japan

Kitakyushu, , Japan

Kochi, , Japan

Kōshi, , Japan

Kumamoto, , Japan

Kurayoshi, , Japan

Matsudo, , Japan

Matsusaka, , Japan

Moriguchi, , Japan

Morioka, , Japan

Nagoya, , Japan

Naha, , Japan

Nakagami, , Japan

Nankoku, , Japan

Nishinomiya, , Japan

Noda, , Japan

Numazu, , Japan

Ohta, , Japan

Okinawa, , Japan

Oyama, , Japan

Ōita, , Japan

Sakai, , Japan

Sapporo, , Japan

Takasaki, , Japan

Takatsuki, , Japan

Tanba, , Japan

Tokyo, , Japan

Tottori, , Japan

Toyama, , Japan

Toyoake, , Japan

Toyonaka, , Japan

Tōgane, , Japan

Tsuyama, , Japan

Ueda, , Japan

Urasoe, , Japan

Uruma, , Japan

Yanagawa, , Japan

Yao, , Japan

Yokkaichi, , Japan

Yokohama, , Japan

Yokosuka, , Japan

Countries

Japan

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=412&filename=CR012625_CSR.pdf

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

Other Identifiers

JNS007ER-JPN-S31

Identifier Type: OTHER

Identifier Source: secondary_id

CR012625

Identifier Type: -

Identifier Source: org_study_id