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Trial record 25 of 34 for:    "Osteoarthritis" | ( Map: Japan )

A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01008618
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : July 10, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Chronic Pain
Osteoarthritis
Low Back Pain
Interventions Drug: Fentanyl
Drug: Placebo
Enrollment 218
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fentanyl (Titration Period) Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period. Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks. Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Period Title: Period 1 (Titration Period)
Started 218 0 0
Completed 150 0 0
Not Completed 68 0 0
Reason Not Completed
Physician Decision             2             0             0
Adverse Event             33             0             0
Withdrawal by Subject             11             0             0
Not satisfied criteria to enter Period 2             20             0             0
Aggravated symptom             2             0             0
Period Title: Period 2 (Double-Blind Period)
Started 0 73 77
Completed 0 37 39
Not Completed 0 36 38
Reason Not Completed
Adverse Event             0             11             2
Withdrawal by Subject             0             3             2
Physician Decision             0             1             0
Insufficient analgesic efficacy             0             0             3
More than 3 times a day rescue treatment             0             0             1
More than 15mm increase in Mean VAS             0             21             29
Not appropriate for this study             0             0             1
Arm/Group Title Fentanyl (Titration Period)
Hide Arm/Group Description One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
Overall Number of Baseline Participants 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants
66.8  (13.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants
Female
145
  66.5%
Male
73
  33.5%
1.Primary Outcome
Title Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
Hide Description Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.
Time Frame Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.
Arm/Group Title Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Overall Number of Participants Analyzed 73 77
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(21.0 to NA)
[1]
The data was not estimable due to the high number of participants censored for this outcome measure.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl (Double-blind Period), Placebo (Double-blind Period)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0846
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Pain Visual Analog Scale (VAS) Score - Titration Period
Hide Description The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.
Time Frame Day 12-14 (Screening period) and Day 27-29 (Titration period)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Titration Period)
Hide Arm/Group Description:
One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
Overall Number of Participants Analyzed 218
Mean (Standard Deviation)
Unit of Measure: mm
Last 3 days in Screening period (n=218) 74.1  (12.37)
Last 3 days in titration period (n=216) 39.71  (21.41)
3.Secondary Outcome
Title Pain Visual Analog Scale (VAS) Score - Double-Blind Period
Hide Description The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.
Time Frame Day 27-29 (Titration period) and Day 83-85 (double-blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Overall Number of Participants Analyzed 73 77
Mean (Standard Deviation)
Unit of Measure: mm
Last 3 days in titration period (n=73, 77) 28.9  (12.71) 29.6  (12.05)
Last 3 days in double-blind period (n=72, 77) 28.9  (18.99) 36.5  (22.29)
4.Secondary Outcome
Title Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
Hide Description The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.
Time Frame Day 1 and 29 or final evaluation (Titration period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Titration Period)
Hide Arm/Group Description:
One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
Overall Number of Participants Analyzed 218
Measure Type: Number
Unit of Measure: Participants
Day 1, Category 1 (n=218) 77
Day 1, Category 2 (n=218) 11
Day 29/Final evaluation, Category 1 (n=218) 183
Day 29/ Final evaluation, Category 2 (n=218) 124
5.Secondary Outcome
Title Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
Hide Description The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.
Time Frame Day 1 and 85 or final evaluation (double-blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Overall Number of Participants Analyzed 73 77
Measure Type: Number
Unit of Measure: Participants
Day 1, Category 1 (n=73, 77) 71 76
Day 1, Category 2 (n=73, 77) 57 63
Day 85/Final evaluation, Category 1 (n=73, 77) 63 56
Day 85/Final evaluation, Category 2 (n=73, 77) 42 35
6.Secondary Outcome
Title Number of Doses of Rescue Treatment Per Day - Titration Period
Hide Description If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.
Time Frame Day 1 and 29 or final evaluation (Titration period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Titration Period)
Hide Arm/Group Description:
One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
Overall Number of Participants Analyzed 218
Mean (Standard Deviation)
Unit of Measure: Treatments per day
Day 1 (n=218) 0.0  (0.19)
Day 29/Final evaluation (n=218) 0.2  (0.45)
7.Secondary Outcome
Title Number of Doses of Rescue Treatment Per Day - Double-Blind Period
Hide Description If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.
Time Frame Day 1 and 85 or final evaluation (double-blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Overall Number of Participants Analyzed 73 77
Mean (Standard Deviation)
Unit of Measure: Treatments per day
Day 1 (n=73, 77) 0.0  (0.16) 0.0  (0.11)
Day 85/Final evaluation (n=72, 77) 0.2  (0.49) 0.2  (0.42)
8.Secondary Outcome
Title Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period
Hide Description The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.
Time Frame Day 1 and 29 or final evaluation (Titration period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Titration Period)
Hide Arm/Group Description:
One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
Overall Number of Participants Analyzed 218
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1 (n=218) 5.9  (1.66)
Day 29/Final evaluation (n=217) 4.0  (2.19)
9.Secondary Outcome
Title Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period
Hide Description The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.
Time Frame Day 1 and 85 or final evaluation (double-blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Overall Number of Participants Analyzed 73 77
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1 (n=73, 77) 3.2  (1.65) 3.2  (1.66)
Day 85/Final evaluation (n=73, 77) 3.2  (1.83) 3.9  (2.08)
10.Secondary Outcome
Title Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period
Hide Description The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Time Frame Day 1 and 29 or final evaluation (Titration period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Titration Period)
Hide Arm/Group Description:
One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
Overall Number of Participants Analyzed 218
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1, Physical Component Score (n=218) 17.1  (14.91)
Day 1, Mental Component Score (n=218) 48.2  (9.92)
Day 29/Final, Physical Component Score (n=217) 23.3  (15.56)
Day 29/Final, Mental Component Score (n=217) 48.5  (9.57)
11.Secondary Outcome
Title Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:
Hide Description The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Time Frame Day 1 and 85 or final evaluation (double-blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Overall Number of Participants Analyzed 73 77
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1, Physical Component Score (n=73, 77) 25.8  (14.71) 22.8  (14.30)
Day 1, Mental Component Score (n=73, 77) 50.1  (8.29) 50.8  (9.13)
Day 85/Final, Physical Component Score (n=73, 77) 24.3  (16.11) 22.5  (14.64)
Day 85/Final, Mental Component Score (n=73, 77) 49.9  (9.82) 51.0  (10.41)
12.Secondary Outcome
Title Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period
Hide Description Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.
Time Frame Day 29 or final evaluation (Titration period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.
Arm/Group Title Fentanyl (Titration Period)
Hide Arm/Group Description:
One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
Overall Number of Participants Analyzed 218
Measure Type: Number
Unit of Measure: Participants
Effective 185
Ineffective 33
13.Secondary Outcome
Title Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
Hide Description Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.
Time Frame Day 1 and 85 or final evaluation (double-blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Arm/Group Title Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
Overall Number of Participants Analyzed 73 77
Measure Type: Number
Unit of Measure: Participants
Day 1, Effective (n= 73, 77) 73 77
Day 1, Ineffective (n= 73, 77) 0 0
Day 85/Final evaluation, Effective (n= 73, 77) 64 51
Day 85/Final evaluation, Ineffective (n= 73, 77) 9 26
Time Frame From Screening period up to the Follow-up period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fentanyl (Titration Period) Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period. Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks. Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
All-Cause Mortality
Fentanyl (Titration Period) Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fentanyl (Titration Period) Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/218 (5.50%)   3/73 (4.11%)   2/77 (2.60%) 
Ear and labyrinth disorders       
Positional vertigo * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Gastrointestinal disorders       
Nausea * 1  3/218 (1.38%)  0/73 (0.00%)  0/77 (0.00%) 
Abdominal pain * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Vomiting * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Gastric discomfort * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Gastric ulcer * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
General disorders       
Pain * 1  1/218 (0.46%)  1/73 (1.37%)  0/77 (0.00%) 
Lassitude * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Death * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Infections and infestations       
Aspiration pneumonia * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Nervous system disorders       
Dizziness * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Somnolence * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Psychiatric disorders       
Delirium * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Hallucinations * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Anxiety * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Vascular disorders       
Chronic heart failure * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fentanyl (Titration Period) Fentanyl (Double-blind Period) Placebo (Double-blind Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   177/218 (81.19%)   50/73 (68.49%)   35/77 (45.45%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/218 (0.46%)  3/73 (4.11%)  0/77 (0.00%) 
Cardiac disorders       
Palpitations * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Angina pectoris * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Atrial fibrillation * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Sinus bradycardia * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Ventricular extrasystoles * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Ear and labyrinth disorders       
Vertigo * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Tinnitus * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Eye disorders       
Diplopia * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Lacrimation increased * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Vision blurred * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Abnormal sensation in eye * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Cataract * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Posterior capsule opacification * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Gastrointestinal disorders       
Nausea * 1  91/218 (41.74%)  5/73 (6.85%)  6/77 (7.79%) 
Constipation * 1  66/218 (30.28%)  6/73 (8.22%)  3/77 (3.90%) 
Vomiting * 1  29/218 (13.30%)  3/73 (4.11%)  1/77 (1.30%) 
Abdominal discomfort * 1  11/218 (5.05%)  1/73 (1.37%)  1/77 (1.30%) 
Diarrhoea * 1  9/218 (4.13%)  0/73 (0.00%)  1/77 (1.30%) 
Abdominal pain * 1  2/218 (0.92%)  1/73 (1.37%)  0/77 (0.00%) 
Stomatitis * 1  2/218 (0.92%)  1/73 (1.37%)  1/77 (1.30%) 
Abdominal pain upper * 1  1/218 (0.46%)  2/73 (2.74%)  0/77 (0.00%) 
Dyspepsia * 1  1/218 (0.46%)  0/73 (0.00%)  1/77 (1.30%) 
Eructation * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Faeces hard * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Gastritis * 1  1/218 (0.46%)  2/73 (2.74%)  0/77 (0.00%) 
Periodontitis * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Epigastric discomfort * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Gingivitis * 1  0/218 (0.00%)  2/73 (2.74%)  0/77 (0.00%) 
Toothache * 1  0/218 (0.00%)  1/73 (1.37%)  1/77 (1.30%) 
Dental caries * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Gastritis atrophic * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Oral discomfort * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Salivary hypersecretion * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
General disorders       
Application site pruritus * 1  12/218 (5.50%)  0/73 (0.00%)  0/77 (0.00%) 
Malaise * 1  9/218 (4.13%)  3/73 (4.11%)  3/77 (3.90%) 
Thirst * 1  4/218 (1.83%)  0/73 (0.00%)  3/77 (3.90%) 
Application site dermatitis * 1  3/218 (1.38%)  1/73 (1.37%)  1/77 (1.30%) 
Feeling abnormal * 1  3/218 (1.38%)  1/73 (1.37%)  1/77 (1.30%) 
Application site erythema * 1  2/218 (0.92%)  1/73 (1.37%)  0/77 (0.00%) 
Drug withdrawal syndrome * 1  2/218 (0.92%)  4/73 (5.48%)  1/77 (1.30%) 
Hypothermia * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Oedema * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Pyrexia * 1  2/218 (0.92%)  2/73 (2.74%)  1/77 (1.30%) 
Application site pain * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Application site rash * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Chest pain * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Oedema peripheral * 1  1/218 (0.46%)  2/73 (2.74%)  1/77 (1.30%) 
Temperature regulation disorder * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Sensation of foreign body * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Application site discomfort * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Application site reaction * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Chest discomfort * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Facial pain * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Fatigue * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Injection site extravasation * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Irritability * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Pain * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Application site eczema * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Hepatobiliary disorders       
Hepatic function abnormal * 1  4/218 (1.83%)  0/73 (0.00%)  2/77 (2.60%) 
Liver disorder * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Immune system disorders       
Seasonal allergy * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  6/218 (2.75%)  10/73 (13.70%)  8/77 (10.39%) 
Chronic sinusitis * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Impetigo * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Tinea pedis * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Urinary tract infection * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Gastroenteritis bacterial * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Cystitis * 1  0/218 (0.00%)  1/73 (1.37%)  1/77 (1.30%) 
Bronchitis * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Herpes zoster * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Pneumonia * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Anal abscess * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Injury, poisoning and procedural complications       
Fall * 1  2/218 (0.92%)  2/73 (2.74%)  1/77 (1.30%) 
Animal bite * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Spinal compression fracture * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Contusion * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Arthropod sting * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Wound * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Skeletal injury * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Investigations       
Blood pressure increased * 1  5/218 (2.29%)  0/73 (0.00%)  2/77 (2.60%) 
Aspartate aminotransferase increased * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Gamma-glutamyltransferase increased * 1  2/218 (0.92%)  0/73 (0.00%)  1/77 (1.30%) 
White blood cell count increased * 1  2/218 (0.92%)  1/73 (1.37%)  0/77 (0.00%) 
Alanine aminotransferase increased * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Blood creatinine increased * 1  1/218 (0.46%)  1/73 (1.37%)  2/77 (2.60%) 
Blood pressure decreased * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Blood urea increased * 1  1/218 (0.46%)  1/73 (1.37%)  1/77 (1.30%) 
C-reactive protein increased * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Electrocardiogram ST segment elevation * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Glucose urine present * 1  1/218 (0.46%)  1/73 (1.37%)  0/77 (0.00%) 
Laboratory test abnormal * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Liver function test abnormal * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Blood alkaline phosphatase increased * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Weight decreased * 1  0/218 (0.00%)  0/73 (0.00%)  2/77 (2.60%) 
Blood potassium decreased * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Electrocardiogram QT prolonged * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Eosinophil count increased * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Blood urine present * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Monocyte count increased * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Protein urine present * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  3/218 (1.38%)  2/73 (2.74%)  5/77 (6.49%) 
Hypophagia * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Dehydration * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Pain in extremity * 1  2/218 (0.92%)  0/73 (0.00%)  2/77 (2.60%) 
Arthritis * 1  1/218 (0.46%)  0/73 (0.00%)  1/77 (1.30%) 
Back pain * 1  1/218 (0.46%)  0/73 (0.00%)  1/77 (1.30%) 
Bursitis * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Chondrocalcinosis pyrophosphate * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Lumbar spinal stenosis * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Muscular weakness * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Musculoskeletal pain * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Neck pain * 1  1/218 (0.46%)  1/73 (1.37%)  0/77 (0.00%) 
Osteoarthritis * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Spinal osteoarthritis * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Musculoskeletal stiffness * 1  1/218 (0.46%)  1/73 (1.37%)  1/77 (1.30%) 
Arthralgia * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Bone pain * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Muscle spasms * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Periarthritis * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Neck mass * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Tenosynovitis stenosans * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Spondylolisthesis * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Uterine leiomyoma * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Nervous system disorders       
Somnolence * 1  59/218 (27.06%)  3/73 (4.11%)  0/77 (0.00%) 
Dizziness * 1  27/218 (12.39%)  1/73 (1.37%)  2/77 (2.60%) 
Headache * 1  15/218 (6.88%)  0/73 (0.00%)  1/77 (1.30%) 
Dysgeusia * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Dysarthria * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Head discomfort * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Hypoaesthesia * 1  1/218 (0.46%)  0/73 (0.00%)  1/77 (1.30%) 
Myelopathy * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Tremor * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Extrapyramidal disorder * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Mental impairment * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Visual field defect * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Psychiatric disorders       
Insomnia * 1  5/218 (2.29%)  7/73 (9.59%)  3/77 (3.90%) 
Hallucination * 1  3/218 (1.38%)  0/73 (0.00%)  0/77 (0.00%) 
Delirium * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Hallucination, visual * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Abnormal behaviour * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Anxiety * 1  0/218 (0.00%)  0/73 (0.00%)  2/77 (2.60%) 
Renal and urinary disorders       
Dysuria * 1  2/218 (0.92%)  1/73 (1.37%)  0/77 (0.00%) 
Pollakiuria * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Haematuria * 1  1/218 (0.46%)  1/73 (1.37%)  0/77 (0.00%) 
Urinary retention * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Benign prostatic hyperplasia * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Reproductive system and breast disorders       
Sexual dysfunction * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Genital haemorrhage * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  4/218 (1.83%)  3/73 (4.11%)  0/77 (0.00%) 
Dysphonia * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Epistaxis * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Hypoxia * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Pleurisy * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Productive cough * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Upper respiratory tract inflammation * 1  1/218 (0.46%)  0/73 (0.00%)  1/77 (1.30%) 
Oropharyngeal pain * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Rhinitis allergic * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Rhinorrhoea * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Oropharyngeal discomfort * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  6/218 (2.75%)  0/73 (0.00%)  2/77 (2.60%) 
Pruritus generalised * 1  6/218 (2.75%)  0/73 (0.00%)  0/77 (0.00%) 
Rash * 1  5/218 (2.29%)  0/73 (0.00%)  0/77 (0.00%) 
Dermatitis contact * 1  3/218 (1.38%)  0/73 (0.00%)  0/77 (0.00%) 
Eczema * 1  2/218 (0.92%)  3/73 (4.11%)  0/77 (0.00%) 
Hyperhidrosis * 1  2/218 (0.92%)  0/73 (0.00%)  0/77 (0.00%) 
Heat rash * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Night sweats * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Rash generalised * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Rash papular * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Skin exfoliation * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Urticaria * 1  1/218 (0.46%)  0/73 (0.00%)  1/77 (1.30%) 
Xeroderma * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Decubitus ulcer * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Photosensitivity reaction * 1  0/218 (0.00%)  1/73 (1.37%)  0/77 (0.00%) 
Piloerection * 1  0/218 (0.00%)  0/73 (0.00%)  1/77 (1.30%) 
Vascular disorders       
Flushing * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Hypertension * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
Raynaud's phenomenon * 1  1/218 (0.46%)  0/73 (0.00%)  0/77 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
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: Director, Clinical Research
Organization: Janssen Research & Development, L.L.C. USA
Phone: 1 609 730-3387
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01008618     History of Changes
Other Study ID Numbers: CR015541
JNS020QD-JPN-N01
First Submitted: November 5, 2009
First Posted: November 6, 2009
Results First Submitted: March 20, 2013
Results First Posted: July 10, 2013
Last Update Posted: December 25, 2013