Back to resultsA Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome
Primary Purpose
Postherpetic Neuralgia, Complex Regional Pain Syndromes (CRPS), Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Fentanyl
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Postherpetic Neuralgia, Complex Regional Pain Syndromes (CRPS), Postoperative Pain, Fentanyl, Patch, transdermal, Opioid analgesics
Eligibility Criteria
Inclusion Criteria:
- Participants whose pain because of post-herpetic neuralgia, Complex Regional Pain Syndrome (CRPS) or post-operative pain syndrome is continuing for at least 12 weeks prior to informed consent
- Participants who are continuously taking a non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days prior to informed consent, or at a certain dose (except the use on an as-needed base) on consecutive days or participants who are continuously taking an analgesic adjuvant with a certain dosage and administration (except the use on an as-needed base) for at least 14 consecutive days prior to informed consent
- Participants showing insufficient therapeutic efficacy of the non-opioid analgesic currently being used, and to requiring a continuous opioid analgesic as per the Investigator or Sub-investigator
- Participants with an average pain intensity of 50 millimeter or more on the Visual Analog Scale in 24-hour daily living prior to informed consent
- Participants who can be hospitalized to the 4th day after the initiation of titration period
Exclusion Criteria:
- Participants who had an operation that may affect the assessment within 30 days before informed consent
- Participants whose main cause of the pain to be assessed is considered attributable to psychogenic pain (physical pain that is caused, increased, or prolonged by mental, emotional, or behavioral factors)
- Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe respiratory function disorders
- Participants complicated with hepatic dysfunction such as fulminant hepatitis (inflammation of the liver) and liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs), or renal impairment such as nephritic syndrome, acute renal failure, and chronic renal failure
- Participants with a history of hypersensitivity to fentanyl and other opioid analgesics
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Fentanyl (Titration period)
Fentanyl (Double-blind period)
Placebo (Double-blind period)
Arm 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 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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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".
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".
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01008553
First Posted
November 5, 2009
Last Updated
June 19, 2013
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT01008553
Brief Title
A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome
Official Title
A Verification Study of JNS020QD in Patients With Post-herpetic Neuralgia, Complex Regional Pain Syndrome (CRPS) or Postoperative Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia, Complex Regional Pain Syndromes (CRPS), Postoperative Pain
Keywords
Postherpetic Neuralgia, Complex Regional Pain Syndromes (CRPS), Postoperative Pain, Fentanyl, Patch, transdermal, Opioid analgesics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl (Titration period)
Arm Type
Experimental
Arm 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 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.
Arm Title
Fentanyl (Double-blind period)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Double-blind period)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
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)
Secondary Outcome Measure Information:
Title
Pain Visual Analog Scale (VAS) Score - Titration Period
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)
Title
Pain Visual Analog Scale (VAS) Score - Double-Blind Period
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)
Title
Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
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)
Title
Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
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)
Title
Number of Doses of Rescue Treatment Per Day - Titration Period
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.
Time Frame
Day 1 and 29 or final evaluation (Titration period)
Title
Number of Doses of Rescue Treatment Per Day - Double-Blind Period
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.
Time Frame
Day 1 and 85 or final evaluation (double-blind period)
Title
Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period
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)
Title
Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period
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)
Title
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period
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)
Title
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period
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)
Title
Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period
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)
Title
Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants whose pain because of post-herpetic neuralgia, Complex Regional Pain Syndrome (CRPS) or post-operative pain syndrome is continuing for at least 12 weeks prior to informed consent
Participants who are continuously taking a non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days prior to informed consent, or at a certain dose (except the use on an as-needed base) on consecutive days or participants who are continuously taking an analgesic adjuvant with a certain dosage and administration (except the use on an as-needed base) for at least 14 consecutive days prior to informed consent
Participants showing insufficient therapeutic efficacy of the non-opioid analgesic currently being used, and to requiring a continuous opioid analgesic as per the Investigator or Sub-investigator
Participants with an average pain intensity of 50 millimeter or more on the Visual Analog Scale in 24-hour daily living prior to informed consent
Participants who can be hospitalized to the 4th day after the initiation of titration period
Exclusion Criteria:
Participants who had an operation that may affect the assessment within 30 days before informed consent
Participants whose main cause of the pain to be assessed is considered attributable to psychogenic pain (physical pain that is caused, increased, or prolonged by mental, emotional, or behavioral factors)
Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe respiratory function disorders
Participants complicated with hepatic dysfunction such as fulminant hepatitis (inflammation of the liver) and liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs), or renal impairment such as nephritic syndrome, acute renal failure, and chronic renal failure
Participants with a history of hypersensitivity to fentanyl and other opioid analgesics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Aichi
Country
Japan
City
Amagasaki
Country
Japan
City
Asahikawa N/A
Country
Japan
City
Asahikawa
Country
Japan
City
Bunkyo
Country
Japan
City
Chigasaki
Country
Japan
City
Chuo
Country
Japan
City
Ebetsu
Country
Japan
City
Fujieda
Country
Japan
City
Fujisawa
Country
Japan
City
Fukuoka N/A
Country
Japan
City
Fukuoka
Country
Japan
City
Hakodate
Country
Japan
City
Hamamatsu
Country
Japan
City
Hatsukaichi
Country
Japan
City
Higashi-Kitami
Country
Japan
City
Hiratsuka
Country
Japan
City
Hirosaki
Country
Japan
City
Hiroshima N/A
Country
Japan
City
Hiroshima
Country
Japan
City
Ichikawa N/A
Country
Japan
City
Ikeda
Country
Japan
City
Isesaki
Country
Japan
City
Itabashi-Ku
Country
Japan
City
Izumo N/A
Country
Japan
City
Izumo
Country
Japan
City
Kakegawa
Country
Japan
City
Kanazawa
Country
Japan
City
Kasama
Country
Japan
City
Kasuga
Country
Japan
City
Kawasaki N/A
Country
Japan
City
Kita-Gun
Country
Japan
City
Kitakyushu
Country
Japan
City
Kitamoto
Country
Japan
City
Kobe
Country
Japan
City
Kochi
Country
Japan
City
Koga
Country
Japan
City
Komatsu
Country
Japan
City
Koshigaya
Country
Japan
City
Kyoto
Country
Japan
City
Maebashi N/A
Country
Japan
City
Maebashi
Country
Japan
City
Matsumoto
Country
Japan
City
Meguro
Country
Japan
City
Miki N/A
Country
Japan
City
Miki
Country
Japan
City
Minato
Country
Japan
City
Miyazaki
Country
Japan
City
Moriguchi
Country
Japan
City
Morioka
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya N/A
Country
Japan
City
Nagoya
Country
Japan
City
Niihama
Country
Japan
City
Nishinomiya
Country
Japan
City
Obihiro
Country
Japan
City
Ohmura
Country
Japan
City
Ohta-Ku
Country
Japan
City
Ohtsu N/A
Country
Japan
City
Ohtsu
Country
Japan
City
Okayama
Country
Japan
City
Onomichi
Country
Japan
City
Osaka
Country
Japan
City
Saga
Country
Japan
City
Sakai
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Setagaya
Country
Japan
City
Shigenobu N/A
Country
Japan
City
Shimotsuga
Country
Japan
City
Shinagawa
Country
Japan
City
Suita N/A
Country
Japan
City
Suita
Country
Japan
City
Suzaka
Country
Japan
City
Tamaho N/A
Country
Japan
City
Tokushima N/A
Country
Japan
City
Tokyo N/A
Country
Japan
City
Tokyo
Country
Japan
City
Ube N/A
Country
Japan
City
Ube
Country
Japan
City
Urayasu N/A
Country
Japan
City
Ureshino
Country
Japan
City
Wakayama
Country
Japan
City
Yachiyo
Country
Japan
City
Yamaguchi
Country
Japan
City
Yamanashi
Country
Japan
City
Yokohama N/A
Country
Japan
City
Yokohama
Country
Japan
City
Yonago N/A
Country
Japan
City
Yubari
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26359327
Citation
Arai T, Kashimoto Y, Ukyo Y, Tominaga Y, Imanaka K. Two placebo-controlled, randomized withdrawal studies to evaluate the fentanyl 1 day patch in opioid-naive patients with chronic pain. Curr Med Res Opin. 2015 Dec;31(12):2207-18. doi: 10.1185/03007995.2015.1092127. Epub 2015 Oct 19.
Results Reference
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A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome
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