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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.

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Extended Release OROSĀ® Paliperidone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia

Secondary outcome: 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

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Evaluating Extended Release OROSĀ® Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia

Starting date: May 2004
Last updated: June 6, 2011

Page last updated: August 23, 2015

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