Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
- Registration Number
- NCT01983111
- Lead Sponsor
- Mundipharma Korea Ltd
- Brief Summary
The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description buprenorphine buprenorphine Patch tramadol/acetaminophen tramadol/acetaminophen Oral tablet
- Primary Outcome Measures
Name Time Method Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment. baseline and 6 weeks NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline.
- Secondary Outcome Measures
Name Time Method Clinical Global Impression of Change(CGIC) 6 weeks The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse.
Patient Global Impressions of Change(PGIC) 6 weeks In the PP set, Number of participants with categorical change in overall satisfaction.
PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration 2 weeks NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline.
Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose Baseline and at 6 weeks EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for 'Motor capability', 'Self-care', 'Daily activities', 'Pain/discomfort', 'Depression/anxiety' and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).
\*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)
EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life.Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS) Baseline and at 6weeks The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results.
Trial Locations
- Locations (1)
Sanggye Paik Hospital, Dept. of Orthopedic Surgery
🇰🇷Seoul, Korea, Republic of