A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28
研究概览
简要总结
The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.
详细描述
Pfizer decided to discontinue additional enrollment into the study effective Sept 5 2010 after assessing the feasibility of completing this study in a realistic timeframe.The study was not stopped for any safety concerns.
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
- 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
- •Patient must have a malignant, solid tumor that has been diagnosed as having metastasized to bone, and must have moderate to severe pain secondary to the bone metastasis at an identifiable reference site.
排除标准
- •The patient who has undergone diagnostic or therapeutic invasive interventions (angiography, biopsy, surgery) less than 15 days prior to study start that would impact their assessment of pain at the reference pain site or area, in the opinion of the investigator.
研究组 & 干预措施
2
干预措施: Placebo (Drug)
1
flexible dosing
干预措施: Pregabalin (Drug)
结局指标
主要结局
Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28
时间窗: Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.
次要结局
- DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment(Baseline, Day 1 to End of Dose Adjustment or ET)
- DAAC From Baseline in Daily Worst Pain, Days 1 Through 28(Baseline, Days 1 through 28 or ET)
- Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4(Baseline, Week 4 or ET)
- Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28(Baseline, Day 0 through Day 28 or ET)
- Patient Global Impression of Change (PGIC)(Weeks 2 and 4 or ET)
- Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28(Baseline, Day 0 through Day 28 or ET)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4(Baseline, Week 4 or ET)
- DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28(Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET)
- Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28(Baseline, Day 14, Day 28 or ET)
- Change From Baseline in mBPI-sf Interference Index Score at Week 4(Baseline, Week 4 or ET)
- Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4(Baseline, Weeks 1, 2, 3 and 4 or ET)
- Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28(Baseline, Day 28 or ET)