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

Mundipharma

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: buprenorphine

Drug: tramadol/acetaminophen

Study type

Interventional

Funder types

Industry

Identifiers

NCT01983111

BUP13-KR-401

Details and patient eligibility

About

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

Enrollment

136 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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