SchizophreniaPhase 3NCT00645307
A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.
A Phase 3 study testing Extended Release OROS® Paliperidone in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study was an Open Label Extension to the recurrence prevention study to evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Extended Release OROS® Paliperidone
- How many people
- 235 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301
- Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated
- Who signed the informed consent for the open-label extension
- And who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open-label extension
Who cannot join
- Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
- Were pregnant or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Evaluating Extended Release OROS® Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia - Open Label Phase
The purpose of the study was an Open Label Extension to the recurrence prevention study to evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.
Read the detailed description
The primary objective of the open-label extension was the long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia. In addition, the long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, as well as quality of life, health economics, and subjective sleep measures, was explored. This open-label extension study followed a recurrence prevention study (R076477-SCH-301) that had both an open-label run-in/stabilization phase and a double-blind, placebo-controlled phase.
Open-label study drug (ER OROS paliperidone 3 mg to 15 mg/day) was administered for 52 weeks.
- Conditions
- Schizophrenia
- Being tested
- Extended Release OROS® Paliperidone
- Keywords
- paliperidone, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Release OROS® PaliperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia
Secondary outcomes (1)
Long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, quality of life, health economics, and subjective sleep measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMay 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645307
- Sponsor's protocol ID
- CR003289
- Status last verified
- Apr 2010
- First submitted
- 24 Mar 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Evaluating Extended Release OROS® Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia - Open Label Phase
- ClinicalTrials.gov ID
- NCT00645307
- Acronym / sponsor ID
- CR003289
- Conditions
- Schizophrenia
- Keywords
- paliperidone, Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was an Open Label Extension to the recurrence prevention study to evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.
Detailed description
The primary objective of the open-label extension was the long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia. In addition, the long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, as well as quality of life, health economics, and subjective sleep measures, was explored. This open-label extension study followed a recurrence prevention study (R076477-SCH-301) that had both an open-label run-in/stabilization phase and a double-blind, placebo-controlled phase.
Open-label study drug (ER OROS paliperidone 3 mg to 15 mg/day) was administered for 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301
- Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated
- Who signed the informed consent for the open-label extension
- And who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open-label extension
Key exclusion criteria (2 listed)
- Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
- Were pregnant or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended Release OROS® Paliperidone | Drug | – |
Primary outcome
Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia
1 secondary outcome
Long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, quality of life, health economics, and subjective sleep measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Evaluating Extended Release OROS® Paliperidone in the Prevention of Recurrence in Subjects With SchizophreniaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extended Release OROS® Paliperidone in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 2 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2011.