QSPainRelief-STRAT: A Questionnaire-based Evaluation of Perceived Clinical Outcome in Patients With Persistent Pain Receiving an Opioid and Non-opioid Treatment Combination, Stratified According to Age and Sex
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Drug-induced sedation
研究概览
简要总结
Investigating the clinical outcomes of drug combinations (opioid + medication acting on the central nervous system) in patients suffering from persistent pain (pain lasting for at least three months) through patient-reported outcomes.
详细描述
This study is part of the QSPainRelief project funded by the European Union's Horizon 2020 research and innovation program (grant agreement 848068; http://qspainrelief.eu).
The QSPainRelief project aims to setup, calibrate and validate a platform to predict the effects of treatment combinations according to patient characteristics such as age and sex (QSPainRelief platform) which integrates recently developed (1) physiologically based pharmacokinetic models to quantitate and adequately predict drug pharmacokinetics in human CNS, (2) target-binding kinetic models; (3) cellular signaling models and (4) a proprietary neural circuit model to quantitate the drug effects on the activity of relevant brain neuronal networks, that also adequately predicts clinical outcome.
To develop the QSPainrelief platform, a large dataset assessing perceived clinical outcome by real-world patients treated with a drug combination and stratified according to age and sex is required. To generate this dataset, we will conduct a questionnaire-based clinical study using an online platform (Redcap) and/or phone interviews to assess baseline patient characteristics and clinical outcome. Eligible patients are any patient treated with an opioid analgesic to whom an add-on treatment acting on the CNS is prescribed.
This study will focus on pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation, drug-induced cognitive dysfunction (memory and attention) and pain medication misuse as adverse effects. These adverse effects have been chosen because they can be readily assessed in patients after a short treatment period using validated patient-reported outcome measures (PROMs).
QSPainRelief-patientSTRAT is a monocentric prospective longitudinal questionnaire-based study conducted in patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged over 18 years.
- •Current treatment with an opioid for the treatment of pain, along with possible other drugs (see Table 1 for the list of eligible opioid medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
- •Decision by the treating physician to introduce an additional non-opioid CNS-acting treatment such as an antiepileptic, an anti-depressant or benzodiazepine (see Table 2 for the list of eligible medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
- •Capacity to understand and provide informed consent.
排除标准
- •Insufficient French language skills.
- •Epilepsy treated by an anti-epileptic.
- •Alzheimer's disease.
- •Parkinson's disease
- •History of cancer diagnosed less than 5 years ago, treated by chemotherapy or radiotherapy.
结局指标
主要结局
Drug-induced sedation
时间窗: 10 days and 3 months
Drug-induced sedation at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences sleepiness, expressed as change in the Stanford Sleepiness Scale score from Day 0 to Day 10 and Month 3
Pain Intensity
时间窗: 10 days and 3 months
The intensity of pain at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences pain relief, expressed as change in pain severity score from Day 0 to Day 10 and Month 3 realized with the Brief Pain Inventory (SF-BPI) pain severity score.
Quality of Life (EURO-QoL)
时间窗: 3 months
The impact on quality of life at 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences quality of life, expressed as change in EuroQOL-5D score from Day 0 to Month 3.
Daily Life Activities
时间窗: 10 days and 3 months
The impact on daily life activities at 10 days and 3 months post-drug combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences daily activities, expressed as change in daily life activities score from Day 0 to Day 10, and Month 3, realized with the Brief Pain Inventory (SF-BPI) daily life activities score.
Drug-induced cognitive dysfunction
时间窗: 10 days and 3 months
. Drug-induced cognitive dysfunction (memory and attention) at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences cognitive functions, expressed as change in the PROMIS Neuro-QOL Short Form Cognitive Function score from Day 0 to Day 10 and Month 3.
次要结局
未报告次要终点