Randomised, Double-blind, Double-dummy, Cross-over Multicenter Study to Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Taking Oxycodone Equivalents of 120 & 160 mg Per Day as Achieved With the Higher OXN PR Tablet Strengths (OXN60/30 mg PR, OXN80/40 mg PR) BID Compared to the Identical Daily Dose Taken as a Combination of Lower Tablet Strengths in Subjects With Non-malignant or Malignant Pain That Requires Around-the-clock Opioid Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 主要终点
- Equivalent bowel function as assessed by the Bowel Function Index (BFI).
研究概览
简要总结
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.
详细描述
Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OXN PR HST
Prolonged release oxycodone/naloxone higher strength tablets
干预措施: Oxycodone (Drug)
OXN PR LST
Prolonged release oxycodone/naloxone lower strength tablets
干预措施: Naloxone (Drug)
结局指标
主要结局
Equivalent bowel function as assessed by the Bowel Function Index (BFI).
时间窗: Week 2, 3 5 and 6 from date of randomisation.
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)
时间窗: 24 hours at one day in week 2, 3 5 and 6 from date of randomisation.
Pain scores based on the mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale. To demonstrate equivalence between multiple lower strength OXN PR tablets and a single higher strength OXN PR tablet taken at the same overall total daily dose
次要结局
- Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.(Up to 35 weeks)
- Pain right now scores at intake of oxycodone/naloxone tablets.(Week 2,3,5 and 6 from date of randomisation)
- Pain scores of subjects average pain over the last 24 hours and rescue medication use.(Week 1,2,3,4,5 and 6 from date of randomisation)
- To assess quality of life based on the EuroQol EQ-5D.(Visit 3 and visit 6 from date of randomisation)
- To assess bowel function (assess BFI and laxative use)(Week 1,2,3,4,5 and 6 from date of randomisation)