NCT01476774已完成3 期
NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline
研究概览
简要总结
This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Males or females age are ≥20 ,≤80 years.
- •Clinical diagnosis of musculoskeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit
- •Subject is a current user of NSAIDS or paracetamol and reports a history of insufficient therapeutic benefit in musculoskeletal pain.
- •Subjects must record an 'average pain over the last week at study institution' score at primary pain site of ≥ 4 on an 11-point numerical pain rating scale.
- •Subjects must be able to understands the study procedures and assessment, and agree to participate in the study by giving written informed consent.
排除标准
- •Subjects who have been taking long-acting or short-acting opioid analgesic formulations within the last 4 weeks.
- •Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to their musculoskeletal pain, requiring frequent analgesic therapy.
- •Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis.
- •Subject who have a past history of malignant neoplasm including leukemia and lymphoma.
- •Subjects with clinically unstable, active or symptomatic heart disease.
- •Subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on.
- •Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period.
- •Subjects scheduled for therapies within the study period which might effect study assessment.
- •Females who are pregnant, lactating or have a possibility of being pregnant.
- •Subjects with values > 2 times the upper limit of normal for AST or ALT or total bilirubin at visit 1 or who have severe impaired liver function.
- •Subjects with serum creatinine > 2 mg/dL at Visit 1 or who have severe impaired renal function.
- •Subjects with serum potassium < 3.5 mEq/L at Visit
- •Subjects receiving hypnotics or other central nervous system (CNS) depressants.
- •Subjects receiving monoamine oxidase inhibitor (MAOI) within 2 weeks before screening.
- •Subjects who have a history of supersensitivity to study drug.
- •Known intolerance to and/or lack of effect of tramadol.
- •Subjects who participated in a clinical research study within 1 month of study entry.
- •Subjects who participated previously in a BTDS study.
研究组 & 干预措施
Buprenorphine Transdermal System
Active Comparator
干预措施: Buprenorphine Transdermal System (Drug)
Tramadol CR
Active Comparator
干预措施: Buprenorphine Transdermal System (Drug)
结局指标
主要结局
The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline
时间窗: 11 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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