Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The change in pain intensity
研究概览
简要总结
The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic non-cancer pain.
详细描述
This trial is a Phase 4, prospective, open-label (meaning that both the research physician and study participants will know which medication is being administered) study of fentanyl transdermal patch-type system (TTS) Durogesic® D-Trans in patients with non-cancer pain. The patch is designed to systematically release the adsorbed fentanyl percutaneously, in a constant rate for three days (72 hours). The study will be conducted for 12 weeks. The efficacy and safety will be evaluated at week 1, week 4, week 8 and week 12 visits. All participants will use the patch at least once during the study. The drug efficacy will be evaluated by the percent change in pain intensity before and after treatment and by improvements in the following activities: daily life, walking, meal intake, mood regulation. The overall safety will be assessed based on the adverse events reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spine related and extremity pain lasting for 3 months or longer
- •pain with Numeric Rating Scale (NRS) at 4 or higher in the past 72 hours
- •good overall health condition based on the medical history and clinical laboratory tests
- •participants using appropriate contraception in case of childbearing potential during the study period.
排除标准
- •history of hypersensitive reaction to narcotic analgesics
- •history of narcotic abuse
- •serious psychotic disorder
- •unable to use transdermal analgesics due to a dermatological condition
- •history of CO2 retention (e.g., chronic obstructive pulmonary disease)
- •surgery in the area with pain within 7 days prior to initiation of the clinical study.
研究组 & 干预措施
Fentanyl-TTS
Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2.
干预措施: Fentanyl-TTS (Drug)
结局指标
主要结局
The change in pain intensity
时间窗: Baseline, 12 weeks
The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.
次要结局
- Change in sleep(12 weeks)
- Satisfaction in study medication(12 weeks)
- Daily dose of prescribed medication(12 weeks)
- Change in functionality(12 weeks)
- The number of participants reporting adverse events (AEs)(12 weeks)