A Phase 3 interventional study of Fentanyl and Placebo in Postherpetic Neuralgia, Complex Regional Pain Syndromes (CRPS) and Postoperative Pain, sponsored by Janssen Pharmaceutical K.K.. Completed at 90 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-07-25.
Sponsored by Janssen Pharmaceutical K.K. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of fentanyl in opioid-naive participants with post-herpetic neuralgia, complex regional pain syndrome or post-operative pain syndrome who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).
This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with post-herpetic neuralgia (intense, typically intermittent pain along the course of a nerve caused by the varicella zoster virus), complex regional pain syndrome or post-operative pain syndrome. The study will consist of titration period (10-29 days) and double-blind period (12 weeks) and the visits will include Day 5-7, 8, 15, 22, 29 in titration period and Day 2-4, 8, 15, 22, 29, 43, 57, 71 and 85 in double-blind period. All the eligible participants will receive 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) of either fentanyl at the dose ranging from 12.5 to 50 microgram/hour or matching placebo. Efficacy will be evaluated primarily by time to withdrawal due to insufficient analgesic efficacy. Participants' safety will be monitored throughout the study.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 258 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Janssen Pharmaceutical K.K. is the lead sponsor of 122 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 will be 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 will be increased up to maximum of 50 mcg/hr. The treatment will continue for 10-29 days and then the eligible participants from this group will be randomly assigned to either of the two groups in the double-blind period.
Drug: Fentanyl
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, will be administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which will be same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will be continued for 12 weeks.
Drug: Fentanyl
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, will be 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) will be gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo will be 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 will continue for 12 weeks.
Drug: Placebo
One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm and thigh and replaced every day.
Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm and thigh and replaced every day.
Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
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)
Pain Visual Analog Scale (VAS) Score - Titration Period
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)
Pain Visual Analog Scale (VAS) Score - Double-Blind Period
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)
Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
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)
Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
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)
Number of Doses of Rescue Treatment Per Day - Titration Period
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.
Time frame: Day 1 and 29 or final evaluation (Titration period)
Number of Doses of Rescue Treatment Per Day - Double-Blind Period
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.
Time frame: Day 1 and 85 or final evaluation (double-blind period)
Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period
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)
Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period
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)
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period
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)
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period
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)
Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period
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)
Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
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)
| Milestone | Fentanyl (Titration Period) | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|---|
| Started | 258 | 0 | 0 |
| Completed | 163 | 0 | 0 |
| Not completed | 95 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 |
| Withdrew: Adverse event | 33 | 0 | 0 |
| Withdrew: Withdrawal by subject | 6 | 0 | 0 |
| Withdrew: Determined to increase dosage | 3 | 0 | 0 |
| Withdrew: Not satisfied criteria to enter period 2 | 50 | 0 | 0 |
| Withdrew: Not appropriate for this study | 1 | 0 | 0 |
| Milestone | Fentanyl (Titration Period) | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|---|
| Started | 0 | 84 | 79 |
| Completed | 0 | 47 | 28 |
| Not completed | 0 | 37 | 51 |
| Withdrew: Physician decision | 0 | 1 | 2 |
| Withdrew: Adverse event | 0 | 14 | 4 |
| Withdrew: Withdrawal by subject | 0 | 2 | 2 |
| Withdrew: Impossible to perform required tests | 0 | 1 | 0 |
| Withdrew: Insufficient analgesic efficacy | 0 | 1 | 4 |
| Withdrew: Rescue drugs increased more than 1 times | 0 | 0 | 3 |
| Withdrew: More than 3 times a day rescue treatment | 0 | 0 | 1 |
| Withdrew: More than 15mm increase in mean vas | 0 | 18 | 35 |
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.
| Days | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|
| Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy | NA (NA to NA) | 45.0 (16.0 to NA) |
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.
| mm | Fentanyl (Titration Period) |
|---|---|
| Baseline (n=258) | 73.5 ± 12.81 |
| Last 3 days in titration period (n=257) | 39.5 ± 20.02 |
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.
| mm | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|
| Baseline (n=84, 79) | 30.1 ± 11.50 | 27.5 ± 11.23 |
| Last 3 days in double-blind period (n=83, 79) | 29.6 ± 21.71 | 37.1 ± 20.19 |
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".
| Participants | Fentanyl (Titration Period) |
|---|---|
| Day 1, Category 1 (n=258) | 85 |
| Day 1, Category 2 (n=258) | 15 |
| Day 29/Final evaluation, Category 1 (n=257) | 220 |
| Day 29/ Final evaluation, Category 2 (n=257) | 146 |
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".
| Participants | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|
| Day 1, Category 1 (n=84, 79) | 82 | 79 |
| Day 1, Category 2 (n=84, 79) | 61 | 67 |
| Day 85/Final evaluation, Category 1 (n=84, 78) | 69 | 56 |
| Day 85/Final evaluation, Category 2 (n=84, 78) | 49 | 32 |
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.
| Treatments per day | Fentanyl (Titration Period) |
|---|---|
| Day 1 (n=258) | 0.1 ± 0.41 |
| Day 29/Final evaluation (n=258) | 0.5 ± 0.72 |
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.
| Treatments per day | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|
| Day 1 (n=84, 79) | 0.1 ± 0.33 | 0.1 ± 0.47 |
| Day 85/Final evaluation (n=84, 79) | 0.4 ± 0.68 | 0.7 ± 0.86 |
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.
| Units on a scale | Fentanyl (Titration Period) |
|---|---|
| Day 1 (n=258) | 5.8 ± 1.66 |
| Day 29/Final evaluation (n=257) | 3.9 ± 1.88 |
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.
| Units on a scale | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|
| Day 1 (n=84, 79) | 3.3 ± 1.64 | 3.1 ± 1.47 |
| Day 85/Final evaluation (n=84, 79) | 3.5 ± 2.27 | 3.7 ± 1.98 |
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.
| Units on a scale | Fentanyl (Titration Period) |
|---|---|
| Day 1, Physical Component Score (n=258) | 23.1 ± 16.67 |
| Day 1, Mental Component Score (n=258) | 41.7 ± 9.75 |
| Day 29/Final, Physical Component Score (n=257) | 26.0 ± 17.55 |
| Day 29/Final, Mental Component Score (n=257) | 45.8 ± 9.77 |
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.
| Units on a scale | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|
| Day 1, Physical Component Score (n=84, 79) | 28.0 ± 16.97 | 29.4 ± 16.98 |
| Day 1, Mental Component Score (n=84, 79) | 47.3 ± 9.22 | 47.7 ± 8.89 |
| Day 85/Final, Physical Component Score (n=84, 79) | 29.9 ± 17.39 | 27.6 ± 16.24 |
| Day 85/Final, Mental Component Score (n=84, 79) | 47.1 ± 11.07 | 47.2 ± 9.61 |
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.
| Participants | Fentanyl (Titration Period) |
|---|---|
| Effective | 214 |
| Ineffective | 44 |
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.
| Participants | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|
| Day 1, Effective (n= 84, 79) | 84 | 79 |
| Day 1, Ineffective (n= 84, 79) | 0 | 0 |
| Day 85/Final evaluation, Effective (n= 84, 79) | 70 | 47 |
| Day 85/Final evaluation, Ineffective (n= 84, 79) | 14 | 32 |
Collected over From Screening period up to the Follow-up period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fentanyl (Titration Period) | — | 13/258 (5%) | 231/258 (89.5%) |
| Fentanyl (Double-blind Period) | — | 8/84 (9.5%) | 71/84 (84.5%) |
| Placebo (Double-blind Period) | — | 4/79 (5.1%) | 56/79 (70.9%) |
| Event | Fentanyl (Titration Period) | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|---|
| PneumoniaInfections and infestations | 1/258 | 0/84 | 1/79 |
| Drug interactionGeneral disorders | 0/258 | 0/84 | 1/79 |
| Drug withdrawal syndromeGeneral disorders | 0/258 | 0/84 | 1/79 |
| FallInjury, poisoning and procedural complications | 0/258 | 0/84 | 1/79 |
| NauseaGastrointestinal disorders | 1/258 | 1/84 | 0/79 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/258 | 1/84 | 0/79 |
| Arteriosclerosis obliteransVascular disorders | 0/258 | 1/84 | 0/79 |
| Gastric ulcer haemorrhageGastrointestinal disorders | 0/258 | 1/84 | 0/79 |
| Urinary retentionRenal and urinary disorders | 0/258 | 1/84 | 0/79 |
| Renal impairmentRenal and urinary disorders | 0/258 | 1/84 | 0/79 |
| Event | Fentanyl (Titration Period) | Fentanyl (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 124/258 | 12/84 | 10/79 |
| SomnolenceNervous system disorders | 118/258 | 12/84 | 5/79 |
| NauseaGastrointestinal disorders | 103/258 | 12/84 | 10/79 |
| DizzinessNervous system disorders | 52/258 | 6/84 | 3/79 |
| DiarrhoeaGastrointestinal disorders | 17/258 | 5/84 | 9/79 |
| VomitingGastrointestinal disorders | 25/258 | 5/84 | 1/79 |
| Decreased appetiteMetabolism and nutrition disorders | 17/258 | 7/84 | 4/79 |
| MalaiseGeneral disorders | 12/258 | 7/84 | 4/79 |
| NasopharyngitisInfections and infestations | 12/258 | 5/84 | 6/79 |
| PruritusSkin and subcutaneous tissue disorders | 13/258 | 5/84 | 0/79 |
| Age Continuous(Years) | Fentanyl (Titration Period) |
|---|---|
| Mean | 66.5 ± 13.89 |
| Sex: Female, Male(Participants) | Fentanyl (Titration Period) |
|---|---|
| Female | 124 |
| Male | 134 |
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Janssen Pharmaceutical K.K.