Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Korea Ltd
• Treatments: Acetaminophen; Buprenorphine; Tramadol

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