A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome
Condition: Postherpetic Neuralgia; Complex Regional Pain Syndromes (CRPS); Postoperative Pain
MeSH terms: Neuralgia; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Neuralgia, Postherpetic; Syndrome; Pain, Postoperative; Somatoform Disorders
Intervention: Fentanyl; Placebo
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.; 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.
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 258.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Postherpetic Neuralgia; Complex Regional Pain Syndromes (CRPS); Postoperative Pain; Fentanyl; Patch, transdermal; Opioid analgesics

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).
    

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