A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 5
- 主要终点
- Pain intensity - BS (box score)-11 pain scale
研究概览
简要总结
This trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (Tridol® SR (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.
详细描述
The primary objective of this non-inferiority study with active, parallel control group is to compare and assess efficacy and safety of buprenorphine transdermal patch (Norspan® Patch 5 mg, 10 mg and 20 mg) and tramadol (Tridol® SR (slow release) Tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. During the period of treatment for 8weeks, titration and maintenance is kept up after 1:1 ratio randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged more than 18 years.
- •Clinical diagnosis of osteoarthritis (OA) of the hip and/or knee including fulfilling the American College of Rheumatology Criteria (ACR criteria L13) and documentation of osteoarthritis in the relevant joint.
- •Patients with moderate to severe osteoarthritis pain in the relevant joint, confirmed by BS-11 (Box Scale-11) more than 4 for their pain on average during the last week, in their primary OA joint, at both the screening and base line visits despite treatment with non-opioid analgesics.
排除标准
- •Patients being treated with high potency opioid analgesics (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (including Norspan®)) for their osteoarthritis pain.
- •Patients who have been taking any opioid analgesics within the last 4 weeks prior to the screening visit.
- •Patients who have been using any (Non-steroidal Anti-Infammatory) NSAID transdermal preparation less than 2 weeks prior to the screening visit.
研究组 & 干预措施
Norspan patch (Buprenorphine TDS)
干预措施: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg (Drug)
TramadolSR tab (Tridol SR tab)
干预措施: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg (Drug)
结局指标
主要结局
Pain intensity - BS (box score)-11 pain scale
时间窗: 8 weeks
次要结局
- Incidence of early discontinuation due to lack of efficacy(8 weeks)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(8 weeks)
- Degree of sleep disturbance due to pain and improvement in quality of sleep(8 weeks)