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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Hide Baseline Characteristics

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  
Number of Participants  
[units: participants]
  491  
Age  
[units: years]
Mean ± Standard Deviation
  36.7  ± 10.44  
Gender  
[units: participants]
 
Female     247  
Male     244  



  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
  Hide More Information

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


No publications provided


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