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.
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00645307
First received: March 24, 2008
Last updated: June 6, 2011
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Extended Release OROS® Paliperidone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Paliperidone
U.S. FDA Resources
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 ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia
Secondary Outcome Measures:
- 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
| Enrollment: | 235 |
| Study Start Date: | May 2004 |
| Study Completion Date: | August 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
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: NCT00645307
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:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00645307 History of Changes |
| Other Study ID Numbers: | CR003289 |
| Study First Received: | March 24, 2008 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
paliperidone Schizophrenia |
Additional relevant MeSH terms:
|
Recurrence Schizophrenia Disease Attributes Pathologic Processes Schizophrenia and Disorders with Psychotic Features Mental Disorders 9-hydroxy-risperidone Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013