A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome
Information source: Janssen Pharmaceutical K.K.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postherpetic Neuralgia; Complex Regional Pain Syndromes (CRPS); Postoperative Pain
Intervention: Fentanyl (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen Pharmaceutical K.K. Official(s) and/or principal investigator(s): Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.
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).
Clinical Details
Official title: A Verification Study of JNS020QD in Patients With Post-herpetic Neuralgia, Complex Regional Pain Syndrome (CRPS) or Postoperative Pain Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
Secondary outcome: Pain Visual Analog Scale (VAS) Score - Titration PeriodPain Visual Analog Scale (VAS) Score - Double-Blind Period Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period Number of Doses of Rescue Treatment Per Day - Titration Period Number of Doses of Rescue Treatment Per Day - Double-Blind Period Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
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
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Aichi, Japan
Amagasaki, Japan
Asahikawa N/A, Japan
Asahikawa, Japan
Bunkyo, Japan
Chigasaki, Japan
Chuo, Japan
Ebetsu, Japan
Fujieda, Japan
Fujisawa, Japan
Fukuoka N/A, Japan
Fukuoka, Japan
Hakodate, Japan
Hamamatsu, Japan
Hatsukaichi, Japan
Higashi-Kitami, Japan
Hiratsuka, Japan
Hirosaki, Japan
Hiroshima N/A, Japan
Hiroshima, Japan
Ichikawa N/A, Japan
Ikeda, Japan
Isesaki, Japan
Itabashi-Ku, Japan
Izumo N/A, Japan
Izumo, Japan
Kakegawa, Japan
Kanazawa, Japan
Kasama, Japan
Kasuga, Japan
Kawasaki N/A, Japan
Kita-Gun, Japan
Kitakyushu, Japan
Kitamoto, Japan
Kobe, Japan
Kochi, Japan
Koga, Japan
Komatsu, Japan
Koshigaya, Japan
Kyoto, Japan
Maebashi N/A, Japan
Maebashi, Japan
Matsumoto, Japan
Meguro, Japan
Miki N/A, Japan
Miki, Japan
Minato, Japan
Miyazaki, Japan
Moriguchi, Japan
Morioka, Japan
Nagasaki, Japan
Nagoya N/A, Japan
Nagoya, Japan
Niihama, Japan
Nishinomiya, Japan
Obihiro, Japan
Ohmura, Japan
Ohta-Ku, Japan
Ohtsu N/A, Japan
Ohtsu, Japan
Okayama, Japan
Onomichi, Japan
Osaka, Japan
Saga, Japan
Sakai, Japan
Sapporo, Japan
Sendai, Japan
Setagaya, Japan
Shigenobu N/A, Japan
Shimotsuga, Japan
Shinagawa, Japan
Suita N/A, Japan
Suita, Japan
Suzaka, Japan
Tamaho N/A, Japan
Tokushima N/A, Japan
Tokyo N/A, Japan
Tokyo, Japan
Ube N/A, Japan
Ube, Japan
Urayasu N/A, Japan
Ureshino, Japan
Wakayama, Japan
Yachiyo, Japan
Yamaguchi, Japan
Yamanashi, Japan
Yokohama N/A, Japan
Yokohama, Japan
Yonago N/A, Japan
Yubari, Japan
Additional Information
Starting date: December 2008
Last updated: June 19, 2013
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