A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 981
- 主要终点
- Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.
研究概览
简要总结
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back, in comparison with placebo and Oxycodone Controlled Release (CR).
详细描述
The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication), phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back. The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside US. The trial will consist of five periods: screening (to assess eligibility), washout (3-7 days with determination of baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level), maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation). The study hypothesis is that the study drug will be more effective than placebo in reducing patients' pain intensity. The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification. The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase. This will be done by looking at the patient's pain diary information. Titrate tapentadol (CG5503) ER (extended release) in 50 mg steps to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 20mg to 50mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with or without food, for a maximum timeframe of 15 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and non-pregnant, non-lactating women having a diagnosis of Lower Back Pain (LBP) of non-malignant origin present for at least 3 months
- •Patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
- •Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to < 160 mg of oral morphine
- •Baseline score of =5 on an 11-point numerical rater scale, calculated as the average pain intensity during the last 3 days prior to randomization.
排除标准
- •History of alcohol and/or drug abuse in Investigator's judgement
- •History of significant liver insufficiency
- •chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months
- •Life-long history of seizure disorder or epilepsy
- •History of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
- •Uncontrolled hypertension
- •Patients with severely impaired renal function
- •Patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function
研究组 & 干预措施
001
tapentadol (CG5503) ER 50 100 150 200 250 mg twice daily for 15 weeks
干预措施: tapentadol (CG5503) ER (Drug)
002
oxycodone CR 10 20 30 40 50 mg twice daily for 15 weeks
干预措施: oxycodone CR (Drug)
003
placebo matching placebo twice daily for 15 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.
时间窗: Baseline and 12 weeks
For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
次要结局
- Responder Analysis 50% Improvement(Baseline and Week 12)
- Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.(Baseline and 12 week endpoint)
- Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.(Baseline and 12 week endpoint)
- Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12(Baseline and 12 week endpoint)
- Number of Participants With Treatment Discontinuation Due to Lack of Efficacy(Baseline and 12 weeks)
- Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12(Baseline and 12 week endpoint)