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

This study has been completed.

First Received: March 31, 2008 Last Updated: April 1, 2008 History of Changes

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00650793

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Extended Release OROS® Paliperidone	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Paliperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Long-term assessment of safety and tolerability of flexibly-dosed ER OROSÂ® paliperidone.

Secondary Outcome Measures:

Assessment of long-term efficacy; Effect on positive and negative symptoms of schizophrenia; Personal and social functioning; Overall functioning; Quality of life parameters

Estimated Enrollment:	387
Study Start Date:	March 2004
Study Completion Date:	February 2006

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650793

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

A 52-week, open-label extension study following a 6-week, double-blind, placebo- and active- controlled study (R076477-SCH-303) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR003376
Study First Received:	March 31, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00650793 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Schizophrenia
paliperidone

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs
Risperidone
Olanzapine

Central Nervous System Depressants
9-hydroxy-risperidone
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
9-hydroxy-risperidone
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009