An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ClinicalTrials.gov Identifier:

NCT00524043

First received: August 30, 2007

Last updated: May 21, 2014

Last verified: May 2014

History of Changes

Results First Received: November 19, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Schizophrenia
Interventions:	Drug: Paliperidone ER Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study began on 21 September 2007 when the first patient was enrolled and ended on 20 November 2008 when the last patient left the study. The study was performed at medical clinics in the United States, India, and Taiwan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who wished to enter the study were screened and, if necessary, had prohibited medications (such as other antipsychotic drugs) washed out for 3 to 5 days before beginning the study. Eligible patients were excluded prior to beginning the study if, for example, they took a prohibited medication.

Reporting Groups

	Description
Placebo	One oral placebo tablet daily for 6 weeks.
Paliperidone ER 6 mg	Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
Paliperidone ER 1.5 mg	Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.

Participant Flow: Overall Study

	Placebo	Paliperidone ER 6 mg	Paliperidone ER 1.5 mg
STARTED	64 ^[1]	70	66
COMPLETED	34	42	35
NOT COMPLETED	30	28	31
Lack of Efficacy	15	13	14
Withdrawal by Subject	5	7	7
Adverse Event	5	2	7
Lost to Follow-up	3	5	3
Various (eg, incarceration)	2	1	0

[1]	One patient was randomly assigned to treatment but did not receive placebo.

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo	One oral placebo tablet daily for 6 weeks.
Paliperidone ER 6 mg	Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
Paliperidone ER 1.5 mg	Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Paliperidone ER 6 mg	Paliperidone ER 1.5 mg	Total
Number of Participants [units: participants]	64	70	66	200
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	64	70	66	200
>=65 years	0	0	0	0
Age [units: years] Mean (Standard Deviation)	36.5 (11.57)	40.3 (12.84)	41.3 (10.96)	39.4 (11.95)
Gender [units: participants]
Female	18	23	16	57
Male	46	47	50	143
Region of Enrollment [units: participants]
India	23	25	24	72
Taiwan	7	12	9	28
United States	34	33	33	100

Outcome Measures

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1. Primary:

Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment). [ Time Frame: Baseline, 6 weeks ]

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2. Secondary:

Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S [ Time Frame: Baseline, 6 weeks ]

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3. Secondary:

Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score [ Time Frame: Baseline, 6 weeks ]

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4. Secondary:

Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score [ Time Frame: Baseline, 6 weeks ]

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5. Secondary:

Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score [ Time Frame: Baseline, 6 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No information from this study about efficacy and safety with treatment beyond 6 weeks. Study not designed to establish efficacy of 6 mg dose relative to 1.5 mg dose. No information on efficacy of paliperidone ER doses between 1.5 and 3 mg.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Clinical Team Leader, Paliperidone
Organization: Johnson & Johnson Pharmaceutical Research & Development
phone: 609 730-2436

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00524043 History of Changes
Other Study ID Numbers:	CR013771 R076477SCH4012
Study First Received:	August 30, 2007
Results First Received:	November 19, 2009
Last Updated:	May 21, 2014
Health Authority:	United States: Food and Drug Administration

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