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临床试验/NCT05088876
NCT05088876终止4 期

Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control - a Randomized, Double-blind, Placebo-controlled, Non-inferiority Study

Insel Gruppe AG, University Hospital Bern4 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2024年8月28日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
7
试验地点
4
主要终点
VAS score (average pain intensity)
研究概览研究设计入排标准研究组 & 干预措施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

Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.

详细描述

Chronic pain patients receiving a strong opioid in combination with paracetamol in a minimum dose of 1.5 g/day will be randomized to receive either paracetamol in the dose already prescribed (group "paracetamol") or an identically looking placebo (group "placebo") using the same schedule during the first study phase (days 1-7). In the second study phase (days 8-14) paracetamol or placebo will be stopped in both arms to assess the effect of pill withdrawal on pain control.

Next to baseline the patients will be instructed to use a pain diary to rate their pain during the study and also document the required opioid rescue doses. Further assessments will include adverse events, subjective ratings of quality of sleep, overall feeling of functioning and quality of life. At the screening visit, patients will also be asked to rate their expected changes in pain relief as a result of co-treatment with paracetamol. At the completion of the study, patients will be asked about their preference and whether, overall, they felt their pain was more poorly controlled during the study.

Adherence will be checked by pill count and measurement of paracetamol blood concentrations. Genotyping of OPRM1, COMT and relevant CYP enzymes and opioid blood concentrations will be assessed as co-variates for pain control.

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

  • •Male and female patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 g/day)
  • •Age ≥ 18 at screening
  • •Ability to understand the study procedures and to provide written informed consent
  • •Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days

排除标准

  • •Participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials
  • •Changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyrone), within the last 7 days preceding randomisation
  • •Surgery within the 14 days preceding randomisation or surgery planned within the duration of the study
  • •Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

Paracetamol

Active Comparator

干预措施: Paracetamol (Drug)

结局指标

主要结局

VAS score (average pain intensity)

时间窗: Study day 7

次要结局

  • Number of withdrawals from study or treatment(During each study phase (days 1-7 and days 8-14))
  • Time (days) of stable pain control(During whole study (days 1-14))
  • Patients' potential to develop hepatotoxicity (investigation of risk factors)(During whole study (days 1-14))
  • % hours with pain/24h(On each study day, up to 14 days)
  • Question about participant's preference(At day 7 and 14)
  • Participant's impression of change(At day 7 and 14)
  • Participants' guess regarding their assigned group (verum or placebo)(At day 7 and 14)
  • Assessment of serious adverse events(During each study phase (days 1-7 and days 8-14))
  • Assessment of specific adverse events: nausea/vomiting(During each study phase (days 1-7 and days 8-14))
  • Assessment of specific adverse events: appetite(During each study phase (days 1-7 and days 8-14))
  • Assessment of specific adverse events: constipation(During each study phase (days 1-7 and days 8-14))
  • Assessment of other adverse events(During each study phase (days 1-7 and days 8-14))
  • Average pain using the Brief Pain Inventory (BPI)(During the last four days of each study phase (days 4-7 und 11-14))
  • Minimum pain using the Brief Pain Inventory (BPI)(During the last four days of each study phase(days 4-7 und 11-14))
  • Worst pain using the Brief Pain Inventory (BPI)(During the last four days of each study phase (days 4-7 und 11-14))
  • Current pain using the Brief Pain Inventory (BPI)(During the last four days of each study phase (days 4-7 und 11-14))
  • Cumulative dose of rescue medication used(During the last four days of each study phase (days 4-7 und 11-14))
  • Number of rescue medication used(During the last four days of each study phase (days 4-7 und 11-14))
  • Percentage increase in pain compared to baseline(During each study phase (days 1-7 and days 8-14))
  • Percentage of patients meeting the predefined pain threshold(During each study phase (days 1-7 and days 8-14))
  • Subjective ratings of quality of sleep using the Brief Pain Inventory (BPI)(At baseline and during each study phase (days 1-7 and days 8-14))
  • Subjective ratings of quality of life using the EQ-5D-5L questionnaire(At baseline and during each study phase (days 1-7 and days 8-14))
  • Subjective ratings of functioning using the Brief Pain Inventory (BPI) and the EQ-5D-5L questionnaire(At baseline and during each study phase (days 1-7 and days 8-14))
  • Patients' expectation regarding pain relief from paracetamol prior to study treatment paracetamol using the Expectation for Treatment Scale (ETS)(Prior to study treatment)
  • Average pain using the Brief Pain Inventory (BPI)(On each study day, up to 14 days)
  • Minimum pain using the Brief Pain Inventory (BPI)(On each study day, up to 14 days)
  • Worst pain using the Brief Pain Inventory (BPI)(On each study day, up to 14 days)
  • Current pain using the Brief Pain Inventory (BPI)(On each study day, up to 14 days)
  • Cumulative dose of rescue medication used(On each study day, up to 14 days)
  • Number of rescue medication used(On each study day, up to 14 days)
  • Time (days) of stable pain control(During whole study (days 1-14))
  • Assessment of specific adverse events: constipation(During each study phase (days 1-7 and days 8-14))
  • Patients' potential to develop hepatotoxicity (investigation of risk factors)(During whole study (days 1-14))
  • Assessment of other adverse events(During each study phase (days 1-7 and days 8-14))
  • Number of withdrawals from study or treatment(During each study phase (days 1-7 and days 8-14))
  • Average pain using the Brief Pain Inventory (BPI)(During the last four days of each study phase (days 4-7 und 11-14))
  • Minimum pain using the Brief Pain Inventory (BPI)(During the last four days of each study phase(days 4-7 und 11-14))
  • Worst pain using the Brief Pain Inventory (BPI)(During the last four days of each study phase (days 4-7 und 11-14))
  • Current pain using the Brief Pain Inventory (BPI)(During the last four days of each study phase (days 4-7 und 11-14))
  • Cumulative dose of rescue medication used(During the last four days of each study phase (days 4-7 und 11-14))
  • Number of rescue medication used(During the last four days of each study phase (days 4-7 und 11-14))
  • Percentage increase in pain compared to baseline(During each study phase (days 1-7 and days 8-14))
  • Percentage of patients meeting the predefined pain threshold(During each study phase (days 1-7 and days 8-14))
  • Subjective ratings of quality of sleep using the Brief Pain Inventory (BPI)(At baseline and during each study phase (days 1-7 and days 8-14))
  • Subjective ratings of quality of life using the EQ-5D-5L questionnaire(At baseline and during each study phase (days 1-7 and days 8-14))
  • Subjective ratings of functioning using the Brief Pain Inventory (BPI) and the EQ-5D-5L questionnaire(At baseline and during each study phase (days 1-7 and days 8-14))
  • Patients' expectation regarding pain relief from paracetamol prior to study treatment paracetamol using the Expectation for Treatment Scale (ETS)(Prior to study treatment)
  • Question about participant's preference(At day 7 and 14)
  • Participant's impression of change(At day 7 and 14)
  • Participants' guess regarding their assigned group (verum or placebo)(At day 7 and 14)
  • Assessment of serious adverse events(During each study phase (days 1-7 and days 8-14))
  • Assessment of specific adverse events: nausea/vomiting(During each study phase (days 1-7 and days 8-14))
  • Assessment of specific adverse events: drowsiness(During each study phase (days 1-7 and days 8-14))
  • Assessment of specific adverse events: appetite(During each study phase (days 1-7 and days 8-14))
  • % hours with pain/24h(On each study day, up to 14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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