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OROS paliperidone

Phase 3

Acute Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Trials Updated: Jun 8, 2011

OROS paliperidone development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2008

OROS paliperidone target and mechanism

ModalitySmall molecule

Also known as ER OROS paliperidone

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials5
Total Enrollment1,183

FDA Designations

No designations recorded

OROS paliperidone clinical trials

OROS paliperidone · 5 trials · 2 indications

Phase 3 3Phase 1 2
NCT00350467A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of SchizophreniaAcute Schizophrenia
COMPLETED288 Analytics
NCT00645307A 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.Schizophrenia
COMPLETED235 Analytics
NCT00650793A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With SchizophreniaSchizophrenia
COMPLETED473 Analytics
PHASE3COMPLETED
A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of Schizophrenia
Acute Schizophrenia
NCT00350467288
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PHASE3COMPLETED
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.
Schizophrenia
NCT00645307235
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PHASE3COMPLETED
A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia
Schizophrenia
NCT00650793473
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Study Endpoints

Primary Endpoints

Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline.
Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia
Long-term assessment of safety and tolerability of flexibly-dosed ER OROS® paliperidone.
to evaluate the effect of food on the pharmacokinetics of ER OROS paliperidone in ambulant healthy men; to evaluate the effect of posture on the pharmacokinetics of ER OROS paliperidone under fasting conditions
A non-inferiority comparison of the orthostatic tolerability of a higher initial dose of paliperidone OROS with the current recommended initial dose of risperidone in patients with schizophrenia

Secondary Endpoints

Changes in PANSS positive and negative scores at each assessment time point from baseline; Changes in CGI-S at each assessment time point from baseline; Changes in PSP at each assessment time point from baseline
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
Assessment of long-term efficacy; Effect on positive and negative symptoms of schizophrenia; Personal and social functioning; Overall functioning; Quality of life parameters
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ER OROS paliperidone and OlanzapineDRUG -
Extended Release OROS® PaliperidoneDRUG -
Extended release OROS paliperidoneDRUG -
extended-release (ER) OROS paliperidoneDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study * DSM-IV diagnosis of schizophrenia (295.10, 29...

Countries:China
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Frequently asked questions about OROS paliperidone

What is OROS paliperidone used for?

OROS paliperidone is being studied for the treatment of acute schizophrenia. It is an extended-release oral formulation evaluated in a Phase 3 clinical trial in adults with acute schizophrenia. The drug is investigational and is not described as approved for this use.

Who is developing OROS paliperidone?

OROS paliperidone is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 3 study of the extended-release oral formulation in acute schizophrenia.

What phase is OROS paliperidone in?

OROS paliperidone is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program remains investigational and is not described as approved.

What clinical trials is OROS paliperidone in?

OROS paliperidone has been studied in one completed Phase 3 trial, NCT00350467. It was a randomized, active-controlled, double-blind, parallel-group study of extended-release paliperidone in acute schizophrenia, enrolling 288 participants in China.

Is OROS paliperidone the same as paliperidone ER?

Yes. OROS paliperidone is also known as paliperidone ER, ER OROS paliperidone, and ER OROS Paliperidone. The same extended-release oral formulation has also been referred to as ER OROS paliperidone and Olanzapine, and OROS paliperidone and Olanzapine.

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