NCT01983111已完成4 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
buprenorphine
Experimental
Patch
干预措施: buprenorphine (Drug)
tramadol/acetaminophen
Active Comparator
Oral tablet
干预措施: tramadol/acetaminophen (Drug)
结局指标
主要结局
Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.
时间窗: 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.
次要结局
- Clinical Global Impression of Change(CGIC)(6 weeks)
- Patient Global Impressions of Change(PGIC)(6 weeks)
- Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration(2 weeks)
- Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose(Baseline and at 6 weeks)
- Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)(Baseline and at 6weeks)
研究者
研究点 (1)
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