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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

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ClinicalTrials.gov Identifier: NCT00650793
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
The purpose of the study was an Open Label Extension to a completed study that evaluated the efficacy and safety of 3 fixed dosages of Extended Release OROS® Paliperidone

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Extended Release OROS® Paliperidone Phase 3

Detailed Description:
This 52-week, open-label extension study followed a 6-week, double-blind, placebo- and active-controlled study (R076477-SCH-303) and was conducted at 52 sites in 11 countries. The primary objective of the open-label extension was the long-term assessment of safety and tolerability of flexibly-dosed ER OROS® paliperidone. The secondary objective was the assessment of long-term efficacy expressed as a function of change in the total Positive and Negative Syndrome Scale (PANSS) score, effect on positive and negative symptoms of schizophrenia by means of change in PANSS factor scores, and personal and social functioning, overall functioning, and quality of life parameters as measured by Personal and Social Performance Scale (PSP), Clinical Global Impression Scale - Severity (CGI-S), and Schizophrenia Quality of Life Scale (SQLS), respectively. Subjects in the open-label phase received flexibly dosed ER OROS® paliperidone (3 mg to 12 mg/day) for 52 weeks

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, DB, PC and AC, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS� Paliperidone (6, 9, 12 mg/Day) and Olanzapine (10 mg/Day), With Open-Label Extension, in the Treatment of Subjects With Schizophrenia - Open Label Phase
Study Start Date : March 2004
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources




Primary Outcome Measures :
  1. Long-term assessment of safety and tolerability of flexibly-dosed ER OROS® paliperidone.

Secondary Outcome Measures :
  1. Assessment of long-term efficacy; Effect on positive and negative symptoms of schizophrenia; Personal and social functioning; Overall functioning; Quality of life parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, 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 phase.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650793


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00650793     History of Changes
Other Study ID Numbers: CR003376
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
paliperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents