An open-labelled multicentric noninferiority randomized controlled trial to compare sublingual Buprenorphine versus oral Tramadol for cancer pain
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 6
- 主要终点
- To compare the analgesic efficacy of sublingual Buprenorphine against oral Tramadol by comparing the NRS pain score between two arms at 14 days after the intervention.
研究概览
简要总结
This study is an open-labeled, multicentric randomized trial comparing the analgesic effect and side effect profile of two opioid analgesics sublingual buprenorphine and oral tramadol for cancer pain. It will be conducted in six centers across India. The primary outcome is pain relief [based on reduction in VAS score], and comparison of the side effect profile [based on numerical opioid side effect scale]. Secondary outcomes include cost comparison between the two arms of the study. This is a non-inferiority study design. If found equally efficacious to tramadol, then this should bring down the treatment cost by 66-70% with lesser abuse potential and toxicities. This could provide evidence for modifications in the guidelines as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Opioid-naive [ not taken any opioid analgesic before the start of the study], Diagnosed to have solid tumors, Suffering from moderate cancer pain [VAS pain of 4-7], who are assessed by the physician and have a life expectancy of more than 3 months attending the palliative and oncology units of trial centers.
排除标准
- •Patients who cannot swallow pills.
- •Patients who are unreliable for follow-up and unable to self-record their pain scores.
- •Patients who give refusal of consent.
- •Patients who have a Life expectancy of lower than 3 months based on evaluation by the physician and performance score.
- •Patients who have severe pain or are terminally ill, psychiatric patients, and patients having brain metastasis.
- •Patients who require adjuvant analgesics other than gabapentin and paracetamol will be excluded from the study.
- •Patients with severe hepatic or renal dysfunction.
结局指标
主要结局
To compare the analgesic efficacy of sublingual Buprenorphine against oral Tramadol by comparing the NRS pain score between two arms at 14 days after the intervention.
时间窗: 2 weeks
次要结局
- To compare the NRS Pain score between two arms of the study at 28days, 56 days, & 84 days after the intervention. To compare the adverse events between the two arms of the study using numerical opioid side effect scores & Current Opioid Misuse Measure at 14 days, 28 days,56 days & 84 days after the intervention.(28 days)
研究者
Dr Sunu Lazar Cyriac
Amala Institute of Medical Sciences