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PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia (PANDORA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00761189
First received: September 25, 2008
Last updated: January 22, 2014
Last verified: January 2014
Results First Received: January 22, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Paliperidone

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paliperidone Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.

Participant Flow:   Overall Study
    Paliperidone
STARTED   491 
COMPLETED   306 
NOT COMPLETED   185 
Adverse Event                42 
Lack of Efficacy                45 
Lost to Follow-up                36 
Withdrawal by Subject                49 
Unspecified                13 



  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.
No text entered.

Reporting Groups
  Description
Paliperidone Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.

Baseline Measures
   Paliperidone 
Overall Participants Analyzed 
[Units: Participants]
 491 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.7  (10.44) 
Gender 
[Units: Participants]
 
Female   247 
Male   244 


  Outcome Measures
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1.  Primary:   Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population   [ Time Frame: Week 12 ]

2.  Primary:   Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population   [ Time Frame: Week 12 ]

3.  Secondary:   Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population   [ Time Frame: Baseline, Week 4 and 12 ]

4.  Secondary:   Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population   [ Time Frame: Baseline, Week 4 and Week 12 ]

5.  Secondary:   Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population   [ Time Frame: Week 12 ]

6.  Secondary:   Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population   [ Time Frame: Week 12 ]

7.  Secondary:   Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population   [ Time Frame: Baseline, Week 4 and 12 ]

8.  Secondary:   Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population   [ Time Frame: Baseline, Week 4 and 12 ]

9.  Secondary:   Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population   [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]

10.  Secondary:   Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population   [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]

11.  Secondary:   Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population   [ Time Frame: Week 12 ]

12.  Secondary:   Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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
Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs Korea
phone: 82-2094-4804



Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00761189     History of Changes
Other Study ID Numbers: CR015079
PAL-KOR-4001
Study First Received: September 25, 2008
Results First Received: January 22, 2014
Last Updated: January 22, 2014
Health Authority: Korea: Food and Drug Administration
Republic of Korea: Food and Drug Administration