An Interventional Study to Compare the Efficacy and Tolerability of Current and Slow Titration With Targin® in the Treatment of Moderate to Severe Non-malignant Chronic Pain (GLORY)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment
研究概览
简要总结
Objectives:
- Objective of main interest
- To assess the drop-out rate caused by adverse event* after 6 weeks treatment
- Further objectives
- To assess the drop-out rate caused by adverse event* after 1 week treatment
- To assess the pain reduction rate after 6 weeks treatment from baseline
- To assess the Euroquol (EQ-5D) quality of life
- To assess physician's overall satisfaction
- To assess subject's overall satisfaction
- To assess safety
详细描述
Study Design (Methodology):
This will be a single center, open-label, randomised, phase IV, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication World Health Organisation (WHO) step II analgesics).
Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is not allowed.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 20 and <80 years of age
- •Patients who have non-malignant chronic pain(≥90 days)
- •Patients who have moderate to severe pain intensity which is not controlled with non-strong opioid
- •Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated for 90 days)
- •Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)
- •Patients who signed a written informed consent form
排除标准
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
- •Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
- •Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
- •Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment
研究组 & 干预措施
Group A
Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
干预措施: Oxycodone/naloxone (Drug)
Group B
Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
干预措施: Oxycodone/naloxone (Drug)
结局指标
主要结局
Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment
时间窗: 6 weeks
To assess the drop-out rate caused by adverse event\* after 6 weeks treatment
次要结局
- The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.(1 week)
- The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.(6 weeks)
- Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug(6 weeks)
- Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug(6 weeks)
- Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug(6weeks)