Gabapentin Versus Transdermal Fentanyl Matrix (TDF) for Chronic Neuropathic Pain (of Radicular Origin): A Multicenter Randomized, Parallel Group, Rater Blinded, Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group
研究概览
简要总结
Gabapentin is a first line medication and fentanyl is second line medication in neuropathic pain. But, there is no head to head study on the efficacy of those medication in neuropathic pain.
The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not inferior to the gabapentin in neuropathic pain.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients are 20 years of age or older
- •patients had chronic pain for more than 3 months and average pain score for last 3 days is not less than 4 (NRS)
- •neuropathic pain caused by the spinal stenosis (radiating pain, motor or sensory change
- •positive MRI finding or radiculopathy was confirmed by the EMG/NCS or not less than 12 points in the S-LANSS score assessment
- •patients who can make out the questionnaire
- •patients have agreed with the informed consent
排除标准
- •patients who have experience with gabapentin, pregabalin, fentanyl matrix, long-acting strong opioid (CR oxycodone, SR morphine)
- •patients who have other causes of neuropathy such as hypothyroidism, Vit B12 deficiency, connective tissue disease, etc.
- •patients who have other disease which causes more pain compared with neuropathic pain
- •patients with a history of drug or alcohol abuse
- •patients who are pregnant or have the possibility of pregnancy
- •patients who are unable to use a transdermal system due to skin disease
- •patients with a serious mental disease
- •patients with a history of hypersensitivity to opioid analgesics
- •patients with a chronic pulmonary disease or respiratory depression
- •patients combined with industrial accidents or traffic accidents
- •at investigator's discretion, any condition where a subject cannot take part in the clinical study on the ground of warning, cautions, and prohibition in study investigator's brochure
研究组 & 干预措施
Transdermal fentany matrix
Transdermal fentanyl matrix is second-line medication on the neuropathic pain but gabapentin is the first-line medication. So, transdermal fentanyl matrix is experimental arm and gabapentin is active comparator arm.
干预措施: transdermal fentanyl matrix, gabapentin (Drug)
gabapentin
Gabapentin is the first-line medication in neuropathic pain. So, gabapentin is active comparator in this study and transdermal fentanyl matrix is experimental.
干预措施: transdermal fentanyl matrix, gabapentin (Drug)
结局指标
主要结局
Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group
时间窗: Visit1 (Day 1), Visit 2 (Day 22-36), Vist3 (Day 50-64)
Post-treatment pain intensity scores will be used to determine the percentage of pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group.
次要结局
- Differences of Oswestry Disability Index score, SF-36, BDI score, investigator and patients global assessment between gabapentin used group and transdermal fentanyl matrix used group(Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64))
研究者
Jae Hyup Lee
Professor
Seoul National University Hospital