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SchizophreniaPhase 3NCT00396565

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

A Phase 3 study testing ER OROS paliperidone and Olanzapine in people with Schizophrenia, run by Janssen Pharmaceutical K.K. at 56 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Schizophrenia
What is being tested?
ER OROS paliperidone and Olanzapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
394 participants
Where
56 sitesJapan
Study dates
Jul 2006to Nov 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

Japan56 sites

  • Study site

    Aizu-Wakamatsu

  • Study site

    Fujioka

  • Study site

    Fujisawa

  • Study site

    Fukui

  • Study site

    Hadano

  • Study site

    Himeji

  • Study site

    Hiratsuka

  • Study site

    Hiroshima

  • Study site

    Ibaraki

  • Study site

    Ichikawa

  • Study site

    Iida

  • Study site

    Inazawa

  • Study site

    Itoman

  • Study site

    Kaizuka

  • Study site

    Kanzaki

  • Study site

    Kashihara

  • Study site

    Kitakyushu

  • Study site

    Kochi

  • Study site

    Kōshi

  • Study site

    Kumamoto

  • Study site

    Kurayoshi

  • Study site

    Matsudo

  • Study site

    Matsusaka

  • Study site

    Moriguchi

  • Study site

    Morioka

  • Study site

    Nagoya

  • Study site

    Naha

  • Study site

    Nakagami

  • Study site

    Nankoku

  • Study site

    Nishinomiya

  • Study site

    Noda

  • Study site

    Numazu

  • Study site

    Ohta

  • Study site

    Ōita

  • Study site

    Okinawa

  • Study site

    Oyama

  • Study site

    Sakai

  • Study site

    Sapporo

  • Study site

    Takasaki

  • Study site

    Takatsuki

  • Study site

    Tanba

  • Study site

    Tōgane

  • Study site

    Tokyo

  • Study site

    Tottori

  • Study site

    Toyama

  • Study site

    Toyoake

  • Study site

    Toyonaka

  • Study site

    Tsuyama

  • Study site

    Ueda

  • Study site

    Urasoe

  • Study site

    Uruma

  • Study site

    Yanagawa

  • Study site

    Yao

  • Study site

    Yokkaichi

  • Study site

    Yokohama

  • Study site

    Yokosuka

Other trials in Japan

About this study

Official title: A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

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.

Read the 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
Being tested
ER OROS paliperidone, Placebo, Olanzapine
Keywords
Schizophrenia, JNS007ER, Positive and Negative Syndrome Scale (PANSS), Paliperidone, Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ER OROS paliperidoneDrug

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

  • PlaceboDrug

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

  • OlanzapineDrug

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

Study groups in NCT00396565
Study groupRoleWhat they receive
ER OROS paliperidoneExperimentalExtended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Receives: Drug: ER OROS paliperidone
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
OlanzapineActive comparatorNot described
Receives: Drug: Olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline and 6 weeks

Secondary outcomes (5)

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score

    The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).

    Measured: Baseline and 6 weeks

  2. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score

    The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).

    Measured: Baseline and 6 weeks

  3. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score

    The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).

    Measured: Baseline and 6 weeks

  4. Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])

    Responders are subjects with 30% or more reduction from baseline in total PANSS score. 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).

    Measured: Baseline and 6 weeks

  5. Change From Baseline in Clinical Global Impression Scale (CGI-S)

    The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00396565
Sponsor's protocol ID
CR012625
Other IDs
JNS007ER-JPN-S31
Status last verified
Apr 2014
First submitted
3 Nov 2006
Last updated
29 Apr 2014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ER OROS paliperidone and Olanzapine in people with Schizophrenia, run by Janssen Pharmaceutical K.K. at 56 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS). (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00396565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.

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