Overview

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