临床试验/CTRI/2025/09/094127

CTRI/2025/09/094127尚未招募2/3 期

Comparative Evaluation of the Analgesic Efficacy of Transdermal Buprenorphine versus Oral Controlled Release Morphine in Patients with Malignancy.

Vardhman Mahavir medical college and Safdarjung hospital1 个研究点分布在 1 个国家目标入组 90 人开始时间: 2025年9月14日最近更新: 2025年9月2日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方
入组人数: 90
试验地点: 1
主要终点: To compare the analgesic effect (using NRS) of transdermal Buprenorphine and Oral controlled release Morphine in patients with malignancy.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a prospective,comparative,randomized and intervention study comparing the analgesic efficacy of transdermal buprenorphine patch with oral controlled-release morphine tablets in patients with malignancy. The primary outcome (analgesic effect) will be calculated using NRS at 24hrs,7 days,3days,14days.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Patients aged 18 to 65 years with malignancy related severe pain (NRS more than or equal to 7).

排除标准

•1.Known hypersensitivity to Buprenorphine or Morphine.
•2.Severe hepatic or renal impairment 3.Significant respiratory depression or uncontrolled comorbidities.
•4.Cognitive impairment preventing self reporting of pain or adverse effects.
•5.History suggestive of substance abuse and mental health illness.
•6.Current use of strong opioids 7.Ongoing parenteral chemotherapy or radiotherapy 8.Pregnancy and lactation.

结局指标

主要结局

To compare the analgesic effect (using NRS) of transdermal Buprenorphine and Oral controlled release Morphine in patients with malignancy.

时间窗: 24hrs,3 days, 7 days, 14 days after administration of drug.

次要结局

To evaluate and compare the patient’s satisfaction and preference using a Likert scale for transdermal Buprenorphine and oral controlled release Morphine in the management of cancer pain.(14 days)
To evaluate the quality of life using FACT-G score with the use of transdermal Buprenorphine patch and oral controlled release Morphine in patients with malignancy.
To evaluate the sleep quality using verbal rating scale with the use of transdermal Buprenorphine patch and oral controlled release Morphine in patients with malignancy

研究者

发起方

Vardhman Mahavir medical college and Safdarjung hospital

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Mohit kumar

VMMC AND SJH

研究点 (1)

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