Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
Condition: Pain
MeSH terms: Pain, Postoperative
Intervention: buprenorphine; tramadol/acetaminophen
Intervention description: Dosage and administration: This one patch should be attached every 7 days.; Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.
Intervention MeSH terms: Acetaminophen; Buprenorphine; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal
      system to tramadol/acetaminophen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Korean men and women aged 20 years or more

          -  Presence of pain associated with a spinal disease and lumbar fusion at 1-2 spinal
             segments (1-2 level lumbar fusion surgery)

          -  Moderate to severe pain of the NRS pain score ≥ 4 at Visit 1 (14~90 days after
             surgery, Baseline) (Amended 21Nov2013)

          -  Consent to participate in the study and voluntary signature on the informed consent
             form

        Exclusion Criteria:

          -  Women of childbearing potential, except for the following cases:

          -  A partner who is vasectomized or otherwise surgically sterile.

          -  Use of 2 contraception methods. Two methods include the combination of double-barrier
             contraception or barrier contraception and hormone contraception, and appropriate
             barrier methods are as follows: Diaphragm (female contraceptive device), condom,
             intrauterine (copper or hormone), sponge or spermicide. Hormonal contraceptives
             include all commercially available products containing estrogen and/or progesterone.

          -  Pregnant or breastfeeding women. Pregnant woman is defined as a woman after
             fertilization to late pregnancy with a positive result from the urine pregnancy test.

          -  History of hypersensitivity to buprenorphine, tramadol, APAP or excipients, and
             celecoxib

          -  Medical history of asthma, acute rhinitis, nasal polyp, vascular edema urticaria or
             allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs(NSAIDs,
             COX-2)

          -  Hypersensitivity or intolerance to Domperidone

          -  Risk of gastrointestinal irritation such as gastrointestinal bleeding, mechanical
             ileus or perforation

          -  Genetic problem such as galactose intolerance, Lapp lactase deficiency or
             glucose-galactose malabsorption

          -  Severely impaired respiratory function or respiratory depression

          -  Current use of monoamine oxidase(MAO) inhibitors or the medication history within 2
             weeks prior to study participation

          -  Convulsive disorder, head injury, shock, decreased level of consciousness of uncertain
             origin, intracranial lesion or increased intracranial pressure or severe hepatic
             impairment

          -  Biliary tract disorder

          -  Presence or suspected drug abuse history

          -  Medical history of opioid or drug dependence

          -  Current use of other CNS inhibitors or muscle relaxants that may result in dyspnea,
             hypotension, severe sedation or coma when used with the investigational product,
             opioid analgesics

          -  Use of strong opioids, buprenorphine or tramadol/APAP within 1 week prior to study
             participation (however, study participation is allowed for PRN prescription of PCA and
             strong opioids)

          -  Any condition representing a contraindication of application of buprenorphine,
             tramadol/APAP or celecoxib

          -  Major pain not attributable to a spinal disease

          -  Anticancer therapy that may affect pain assessment

          -  Clinically significant cardiovascular or renal dysfunction

          -  Postoperative complications

          -  Symptoms of acute pain after lumbar fusion or characteristic analgesic features
             showing rapidly changing needs for analgesics

          -  Current use of other investigational product at enrollment or within 30 days after
             administration of other investigational product