NCT03498014撤回不适用
Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Compare presence/absence undesirable events associated to opioid between groups from predefined list
研究概览
简要总结
The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.
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, Outcomes Assessor)
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
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is at least 18 years old
- •The patient will be available for all visits
- •Patients suffer from non-cancerous chronic pain according to HAS criteria
- •Patient not having taking opioids in previous 2 months
- •Patient indicated for prescription of opioids (oxycodone, codeine or tramadol) or patient not responding to first line treatment
排除标准
- •The subject is participating in an category I interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant or breastfeeding
- •The patient is likely to procreate and does not use an effective method of contraception (contraceptive ring, surgical contraception, implant, patch, contraceptive pill, male and female condoms, IUD)
- •There is a contra-indication for opioid use
- •Patient with an addiction risk (score ≥ 8 on ORT scale).
结局指标
主要结局
Compare presence/absence undesirable events associated to opioid between groups from predefined list
时间窗: Month 3
Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol
Compare presence/absence undesirable events associated to opioid between groups
时间窗: Month 3
Presence/absence of at least one undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
次要结局
- Compare observed medication misuse between groups(Month 3)
- Compare benefit/risk ratio of treatment between groups(Month 3)
- Compare quality of life between patients in each group(Month 3)
- Qualitive comparison of medication compliance between groups(Month 3)
- Compare patient-reported pain between groups(Month 3)
- Compare neuropathic pain between groups(Month 3)
- Correlation between predicted phenotype and observed metabolic ratios(Month 3)
- Metabolic profile of patients(Month 3)
- Correlation between saliva and plasma concentration of opioids(Month 3)
- Compare medication compliance between groups(Month 3)
- Compare clinical therapeutic efficacy between groups(Month 3)
- Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)(Day 0)
- Number of undesirable events associated to opioid between groups(Month 3)
研究者
研究点 (2)
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