Back to resultsA 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
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Extended Release OROS® Paliperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, paliperidone
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Long-term assessment of safety and tolerability of flexibly-dosed ER OROS® 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
Full Information
NCT ID
NCT00650793
First Posted
March 31, 2008
Last Updated
June 6, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00650793
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, paliperidone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
473 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Extended Release OROS® Paliperidone
Primary Outcome Measure Information:
Title
Long-term assessment of safety and tolerability of flexibly-dosed ER OROS® paliperidone.
Secondary Outcome Measure Information:
Title
Assessment of long-term efficacy; Effect on positive and negative symptoms of schizophrenia; Personal and social functioning; Overall functioning; Quality of life parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21155708
Citation
Kozma C, Dirani R, Canuso C, Mao L. Change in employment status over 52 weeks in patients with schizophrenia: an observational study. Curr Med Res Opin. 2011 Feb;27(2):327-33. doi: 10.1185/03007995.2010.541431. Epub 2010 Dec 15.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=524&filename=CR003376_CSR.pdf
Description
A 52-week, open-label extension study following a 6-week, double-blind, placebo- and active- controlled study (R076477-SCH-303)
Learn more about this trial
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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