A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change from baseline in average Numeric Rating Scale (NRS) pain intensity score
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS).
Secondary Objectives are:
- To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life;
- To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain;
- To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment;
- To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain;
- To assess endocannabinoid plasma concentrations.
详细描述
The total study duration for a participant is 6 weeks (1-week screening, 4-week treatment and 1-week post-treatment follow-up).
Participants continue to receive WHO Step 2 or 3 cancer pain treatment as background therapy.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SSR411298 200 mg
SSR411298 200 mg, one tablet once daily for 4 weeks
干预措施: SSR411298 (Drug)
Placebo
Placebo (for SSR411298), one tablet once daily for 4 weeks
干预措施: Placebo (for SSR411298) (Drug)
结局指标
主要结局
Change from baseline in average Numeric Rating Scale (NRS) pain intensity score
时间窗: 5 weeks (from D-7 (seven days before randomization) up to D28)
The NRS is an 11-category descriptive anchor scale that is one of the most frequently employed and accepted scales for pain evaluation. Score ranges from 0 \[no pain\] to 10 \[worst possible pain\]. Average NRS score is defined as the average of pain intensity scores measured daily by NRS during a week.
次要结局
- Change from baseline in Brief Pain Inventory Short-Form (BPI-SF) scores(5 weeks (from D-7 (seven days before randomization) up to D28))
- Responder rates(5 weeks (from D-7 (seven days before randomization) up to D28))
- Breakthrough pain frequency(5 weeks (from D-7 (seven days before randomization) up to D28))
- Opioid consumption expressed as the morphine-equivalent dose per day(5 weeks (from D-7 (seven days before randomization) up to D28))
- Rescue medication consumption expressed as the number of rescue medication doses per day(5 weeks (from D-7 (seven days before randomization) up to D28))
- Mood disorders as measured by the Hospital, Anxiety & Depression Scale (HADS)(5 weeks (from D-7 (seven days before randomization) up to D28))
- Change in nausea as measured by Visual Analog Scale (VAS)(5 weeks (from D-7 (seven days before randomization) up to D28))
- Constipation as measured by the Bowel Function Index (BFI)(5 weeks (from D-7 (seven days before randomization) up to D28))
- Healthcare utilization(5 weeks (from D-7 (seven days before randomization) up to D28))
- Patient satisfaction of pain relief(5 weeks (from D-7 (seven days before randomization) up to D28))
- Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) version 3(5 weeks (from D-7 (seven days before randomization) up to D28))
- Overview of adverse events (AE)(up to 5 weeks (from 1st study drug intake up to 7 days after last study drug intake))
- SSR411298 plasma concentration(predose and 3-5 hours after study drug intake on Day D14 and Day 28)