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Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release (ER) Tablets in the Treatment of Adult Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00077714
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE February 11, 2004
First Posted Date  ICMJE February 16, 2004
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
Change from baseline in total PANSS score to the end of the double-blind phase.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00077714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
Changes from baseline to the end of the double-blind phase in PSP, CGI-S, and SQLS-R4.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release (ER) Tablets in the Treatment of Adult Patients With Schizophrenia
Official Title  ICMJE A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Paliperidone Extended Release Tablets and Olanzapine, With Open-label Extension, in the Treatment of Patients With Schizophrenia
Brief Summary The purpose of this trial is to determine if paliperidone ER is an effective treatment for adults with schizophrenia.
Detailed Description

Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia. The extended-release (ER) formulation of paliperidone was developed to deliver paliperidone at a relatively constant rate over a 24-hour period to improve the tolerability profile and decrease the potential for orthostatic hypotension. This study is designed to evaluate the efficacy, safety and tolerability of 2 fixed dosages of paliperidone ER compared with placebo in adult patients with schizophrenia. This is a multicenter, double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), randomized (patients will be assigned to different treatment groups based solely on chance), placebo- and active-controlled, parallel-group, dose-response study. Patients will be randomized into 1 of 4 treatment groups to receive oral dosages of paliperidone ER 6 mg or 12 mg, olanzapine 10 mg, or placebo once daily for a 6-week period. The study includes a screening period of up to 5 days, followed by 6-week double-blind treatment phase. Following the double-blind treatment phase, eligible patients (those who have completed the 6-week double-blind phase or who discontinue due to lack of efficacy after a minimum of 21 days) may enter a 52-week open-label extension phase with paliperidone ER monotherapy. While patients are hospitalized, efficacy will be assessed twice during the first week and at the end of the second week, and after patients are discharged from the hospital, they will return to have efficacy and safety assessments performed on a weekly basis through the end of the 6-week double-blind phase. Efficacy will be evaluated throughout the 6-week double-blind phase by completion of the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4), and Sleep Visual Analog Scale (VAS). The efficacy response will be measured by the change from baseline score to end of double-blind phase for PANSS, PSP, CGI-S, SQLS-R4, and Sleep VAS. Safety will be monitored throughout the study and includes assessments of the incidence of adverse events; measurement of extrapyramidal symptoms using 3 rating scales (Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Rating Scale [BARS], Simpson-Angus Rating Scale [SAS]); measurement of vital signs (laying down and standing blood pressure, pulse, temperature); electrocardiograms; and clinical laboratory tests. Double-blind: 6 mg or 12 mg fixed dose of paliperidone ER, olanzapine 10 mg or matching placebo taken orally once daily for 6 weeks.

Open-label extension: start on paliperidone ER 9 mg taken orally once daily; maintained on a flexible dosage of paliperidone ER (3, 6, 9, or 12 mg/day) for 52 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Paliperidone ER
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2010)
12
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
440
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
  • experiencing an acute episode, with a total PANSS score at screening between 70 and 120
  • agree to voluntary hospitalization for a minimum of 14 days. Open-label phase: must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy.

Exclusion Criteria:

  • DSM-IV axis I diagnosis other than schizophrenia
  • DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
  • history of neuroleptic malignant syndrome (NMS)
  • history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
  • previous history of lack of response to risperidone when acutely psychotic
  • significant risk of suicidal or violent behavior.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00077714
Other Study ID Numbers  ICMJE CR004378
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP