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

NCT00396565 | Completed Phase 3 Results

• 2 other identifiers: CR012625JNS007ER-JPN-S31
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 56

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; JNS007ER; Positive and Negative Syndrome Scale (PANSS); Paliperidone; Extended 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 paliperidone DRUG

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

ER OROS paliperidone

Placebo DRUG

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

Placebo

Olanzapine DRUG

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

Olanzapine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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)
• Patients who have acute symptoms of schizophrenia
• Both inpatients and outpatients are acceptable

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (56)

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Aizu-Wakamatsu, Japan

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Fujioka, Japan

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Fujisawa, Japan

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Fukui, Japan

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Hadano, Japan

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Himeji, Japan

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Hiratsuka, Japan

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Hiroshima, Japan

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Ibaraki, Japan

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Ichikawa, Japan

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Iida, Japan

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Inazawa, Japan

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Itoman, Japan

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Kaizuka, Japan

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Kanzaki, Japan

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Kashihara, Japan

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Kitakyushu, Japan

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Kochi, Japan

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Kōshi, Japan

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Kumamoto, Japan

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Kurayoshi, Japan

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Matsudo, Japan

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Matsusaka, Japan

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Moriguchi, Japan

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Morioka, Japan

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Nagoya, Japan

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Naha, Japan

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Nakagami, Japan

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Nankoku, Japan

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Nishinomiya, Japan

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Noda, Japan

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Numazu, Japan

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Ohta, Japan

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Okinawa, Japan

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Oyama, Japan

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Ōita, Japan

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Sakai, Japan

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Sapporo, Japan

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Takasaki, Japan

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Takatsuki, Japan

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Tanba, Japan

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Tokyo, Japan

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Tottori, Japan

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Toyama, Japan

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Toyoake, Japan

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Toyonaka, Japan

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Tōgane, Japan

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Tsuyama, Japan

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Ueda, Japan

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Urasoe, Japan

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Uruma, Japan

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Yanagawa, Japan

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Yao, Japan

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Yokkaichi, Japan

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Yokohama, Japan

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Yokosuka, Japan

Location

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

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

81-3-4411-5652

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

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 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 29, 2014
• Results First Posted: July 3, 2012

Record last verified: 2014-04

Locations

JP (56)