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Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants (PASS)

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ClinicalTrials.gov Identifier: NCT00761605
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : March 6, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone
Enrollment 387
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Period Title: Overall Study
Started 387
Completed 246
Not Completed 141
Reason Not Completed
Adverse Event             26
Death             2
Lack of Efficacy             26
Lost to Follow-up             29
Withdrawal by Subject             37
Other             21
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Overall Number of Baseline Participants 387
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 387 participants
36.73  (10.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 387 participants
Female
214
  55.3%
Male
173
  44.7%
1.Primary Outcome
Title Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
Hide Description The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 277 78 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 99.84  (70.35) 73.03  (57.60) 67.66  (58.86)
Change at Week 24 13.09  (57.78) 8.87  (33.17) 10.50  (42.33)
2.Secondary Outcome
Title Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
Hide Description The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.
Arm/Group Title Paliperidone (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Overall Number of Participants Analyzed 277 78 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 56.03  (15.51) 63.62  (11.76) 63.44  (16.07)
Change at Week 24 -5.81  (11.73) -3.77  (8.12) -4.59  (11.32)
3.Secondary Outcome
Title Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Hide Description The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment."N" (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title Paliperidone (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Overall Number of Participants Analyzed 276 78 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 70.61  (17.09) 76.67  (18.40) 80.50  (17.01)
Change at Week 24 -1.54  (14.62) -2.33  (15.11) -1.06  (13.87)
4.Secondary Outcome
Title Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
Hide Description Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment."N" (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title Paliperidone (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Overall Number of Participants Analyzed 277 77 32
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
Baseline 65.62  (30.52) 70.89  (24.90) 62.45  (30.96)
Change at Week 24 1.74  (36.00) 3.66  (27.79) -1.94  (34.18)
5.Secondary Outcome
Title Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
Hide Description Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment."N" (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title Paliperidone (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Overall Number of Participants Analyzed 277 77 32
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
Baseline 43.27  (31.65) 39.40  (28.02) 44.47  (28.12)
Change at Week 24 4.80  (33.31) 2.42  (30.84) 7.83  (36.24)
6.Secondary Outcome
Title Change From Baseline in Krawiecka Scale Score at Week 24
Hide Description Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.
Arm/Group Title Paliperidone (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Overall Number of Participants Analyzed 277 78 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 5.38  (3.28) 4.74  (2.99) 4.38  (3.02)
Change at Week 24 1.43  (2.62) 1.32  (1.94) 1.69  (2.72)
7.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
Hide Description The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.
Arm/Group Title Paliperidone (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Overall Number of Participants Analyzed 277 78 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 3.77  (1.16) 3.46  (0.98) 3.25  (1.05)
Change at Week 24 0.70  (1.04) 0.47  (0.86) 0.47  (0.95)
8.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24
Hide Description The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title Paliperidone (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
Overall Number of Participants Analyzed 268 76 31
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 3.63  (0.91) 3.66  (0.60) 3.48  (1.00)
Change at Week 24 0.46  (1.23) 0.37  (0.96) 0.35  (1.17)
Time Frame Baseline up to Week 24
Adverse Event Reporting Description Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
 
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
All-Cause Mortality
Paliperidone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone
Affected / at Risk (%)
Total   38/387 (9.82%) 
Cardiac disorders   
Acute myocardial infarction * 1  1/387 (0.26%) 
Endocrine disorders   
Hyperprolactinaemia * 1  1/387 (0.26%) 
Injury, poisoning and procedural complications   
Overdose * 1  1/387 (0.26%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc degeneration * 1  1/387 (0.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer stage IV * 1  1/387 (0.26%) 
Metastases to liver * 1  1/387 (0.26%) 
Nervous system disorders   
Headache * 1  1/387 (0.26%) 
Syncope * 1  1/387 (0.26%) 
Psychiatric disorders   
Acute psychosis * 1  1/387 (0.26%) 
Aggression * 1  1/387 (0.26%) 
Anxiety * 1  1/387 (0.26%) 
Completed suicide * 1  5/387 (1.29%) 
Delusion * 1  3/387 (0.78%) 
Hallucination * 1  2/387 (0.52%) 
Hallucination, auditory * 1  3/387 (0.78%) 
Insomnia * 1  1/387 (0.26%) 
Panic attack * 1  1/387 (0.26%) 
Psychiatric symptom * 1  1/387 (0.26%) 
Psychotic disorder * 1  7/387 (1.81%) 
Schizophrenia * 1  5/387 (1.29%) 
Suicide attempt * 1  3/387 (0.78%) 
Surgical and medical procedures   
Cholecystectomy * 1  1/387 (0.26%) 
Gastrectomy * 1  1/387 (0.26%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paliperidone
Affected / at Risk (%)
Total   209/387 (54.01%) 
Endocrine disorders   
Hyperprolactinaemia * 1  8/387 (2.07%) 
Eye disorders   
Oculogyration * 1  8/387 (2.07%) 
Gastrointestinal disorders   
Constipation * 1  13/387 (3.36%) 
Nausea * 1  11/387 (2.84%) 
Infections and infestations   
Nasopharyngitis * 1  9/387 (2.33%) 
Investigations   
Weight decreased * 1  10/387 (2.58%) 
Weight increased * 1  36/387 (9.30%) 
Musculoskeletal and connective tissue disorders   
Muscle rigidity * 1  15/387 (3.88%) 
Nervous system disorders   
Akathisia * 1  44/387 (11.37%) 
Bradykinesia * 1  9/387 (2.33%) 
Dizziness * 1  16/387 (4.13%) 
Extrapyramidal disorder * 1  8/387 (2.07%) 
Headache * 1  33/387 (8.53%) 
Sedation * 1  10/387 (2.58%) 
Somnolence * 1  20/387 (5.17%) 
Tremor * 1  23/387 (5.94%) 
Psychiatric disorders   
Anxiety * 1  22/387 (5.68%) 
Depression * 1  11/387 (2.84%) 
Hallucination, auditory * 1  8/387 (2.07%) 
Insomnia * 1  48/387 (12.40%) 
Reproductive system and breast disorders   
Amenorrhoea * 1  15/387 (3.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
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.
Results Point of Contact
Name/Title: Senior Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs Korea
Phone: 82-2-2094-4804
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00761605     History of Changes
Other Study ID Numbers: CR015253
PAL-KOR-4003
First Submitted: September 25, 2008
First Posted: September 29, 2008
Results First Submitted: January 24, 2014
Results First Posted: March 6, 2014
Last Update Posted: September 10, 2014