Clinical trial NCT01983111: Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
Official title: A Multicenter, Phase IV, Interventional Study to Compare the Efficacy and Safety of NORSPAN to Tramadol/Acetaminophen in Patients With Prolonged Postoperative Pain After Spinal Surgery (PASSION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration
timeFrame: 2 weeks
measure: Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose
timeFrame: Baseline and at 6 weeks
measure: Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)
timeFrame: Baseline and at 6weeks
measure: Clinical Global Impression of Change(CGIC)
timeFrame: 6 weeks
measure: Patient Global Impressions of Change(PGIC)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanggye Paik Hospital, Dept. of Orthopedic Surgery
Study officials:
affiliation: Sanggye Paik Hospital, Dept. of Orthopedic Surgery
name: Jinhyok Kim, Dr.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Kim JH, Kim JH, Kim HS, Min WK, Park YS, Lee KY, Lee JH. Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery. Pain Res Manag. 2017;2017:2071494. doi: 10.1155/2017/2071494. Epub 2017 Sep 13.