Clinical trial NCT01008553: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postherpetic Neuralgia
Complex Regional Pain Syndromes (CRPS)
Postoperative Pain
Keywords: Postherpetic Neuralgia
Complex Regional Pain Syndromes (CRPS)
Postoperative Pain
Fentanyl
Patch, transdermal
Opioid analgesics
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 258
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
timeFrame: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)
Secondary outcomes:
measure: Pain Visual Analog Scale (VAS) Score - Titration Period
timeFrame: Day 12-14 (Screening period) and Day 27-29 (Titration period)
measure: Pain Visual Analog Scale (VAS) Score - Double-Blind Period
timeFrame: Day 27-29 (Titration period) and Day 83-85 (double-blind period)
measure: Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
timeFrame: Day 1 and 29 or final evaluation (Titration period)
measure: Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
measure: Number of Doses of Rescue Treatment Per Day - Titration Period
timeFrame: Day 1 and 29 or final evaluation (Titration period)
measure: Number of Doses of Rescue Treatment Per Day - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
measure: Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period
timeFrame: Day 1 and 29 or final evaluation (Titration period)
measure: Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
measure: Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period
timeFrame: Day 1 and 29 or final evaluation (Titration period)
measure: Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
measure: Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period
timeFrame: Day 29 or final evaluation (Titration period)
measure: Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
Other outcomes:
Locations:
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
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References:
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.