Clinical Trial: Trial Evaluating the Safety and Efficacy of 2 Doses of ER OROS Paliperidone in Acute Adult Schizophrenics

This study has been completed.

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

Purpose

The purpose of this trial is to determine if ER OROS Paliperidone is an effective treatment for adults with acute schizophrenia.

Condition Treatment or Intervention Phase
Schizophrenia
 Drug: ER OROS Paliperidone
Phase III

MedlinePlus related topics:  Schizophrenia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  440

Study start: February 2004;  Study completion: November 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

  • Age must be 18 years of age or older.
  • Subjects must have been diagnosed with schizophrenia according to DSM-IV (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening.
  • Subjects must be experiencing an acute episode, with a total PANSS score at screening between 70 and 120.
  • Subjects must agree to voluntary hospitalization for a minimum of 14 days.

Location Information


Louisiana
      J. Gary Booker, MD, Shreveport,  Louisiana,  71101,  United States

More Information

Study ID Numbers:  R076477-SCH-304; schizophrenia
Record last reviewed:  November 2004
Last Updated:  November 19, 2004
Record first received:  February 11, 2004
ClinicalTrials.gov Identifier:  NCT00077714
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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