Predictive Markers of the Effects of Opioid Therapy (ABILITY)
2016年5月11日 更新者：University of Aarhus
Predictive Markers of the Effects of Opioid Therapy in Opioid naïve Patients With Chronic Pain: an International, Multi-centre, Observational Cohort Study (ABILITY)
The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by developing an implementable clinical computerised decision support system based on individual patient characteristics.
The investigators hypothesize that successful pain control with opioids can be predicted before treatment initiation with advanced data analyses of data originating from pre-treatment EEG, QST and pain-related catastrophic thinking.
The primary objective of this study is the identification of markers that can be used to individualize treatment recommendations, i.e. to reliably predict the response of pain to opioids.
Markers are selected among the most promising data and machine-learning methods are used for the prediction. This includes determining the associations between a battery of selected pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in opioid naïve chronic pain patients, including indication and responder identification.
The key secondary objectives are as follows: to investigate pre-treatment clinical predictive markers as predictors of opioid treatment efficacy and effectiveness in terms of the following:
- Pain intensity and unpleasantness
- Use of rescue analgesics
- Physical functioning
- Global improvement and satisfaction with treatment
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
62
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aarhus C、丹麦、8000
- Department of Rheumatology, Aarhus University Hospital
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Give、丹麦、7323
- Friklinikken
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Ringsted、丹麦、4100
- Hospitalet Valdemar
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Ljubljana、斯洛文尼亚、1000
- Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
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Pellenberg
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Leuven、Pellenberg、比利时、3212
- KU Leuven and the Leuven Centre for Algology & Pain Management
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Subjects with an insufficiently treated chronic pain condition (with non-opioids ± adjuvants), and expected to benefit from the administration of opioids (as necessary) to obtain freedom from pain.
描述
Inclusion Criteria:
- Pain duration ≥ 3 months.
- Minimum baseline pain intensity ≥ 4 on a 0-10 numerical rating scale (over the past week).
- Maximum baseline pain intensity < 9 on a 0-10 numerical rating scale (over the past week).
- Prescribed opioid treatment (ATC: N02)
- Anticipated to stay on prescribed opioid treatment throughout the study, i.e. >14 days.
- Anticipated to stay on any concomitant non-opioid treatment throughout the study, i.e. >14 days.
- Subject may be male or female, age >18 years old.
- Is willing and able to comply with study procedures as judged by the site investigator.
- Subject has voluntarily signed and dated the study-specific informed consent form, approved by an Independent Ethics Committee, after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent form must be signed before any study-specific procedures are performed.
Exclusion Criteria:
- Has a mental incapacity or language barriers precluding adequate understanding of study procedures.
- Is considered by the site investigator unsuitable to participate in the study for any other reason, for instance due to a significant serious underlying condition.
- Recently received opioids on a daily basis (within the last 10 weeks).
- Current alcohol or substance abuse, according to the site investigator's medical judgement.
- Is anticipated to undergo a painful procedure(s) (e.g. surgery) during the study, which can interfere with the experience of the chronic pain condition for which the subject is to receive opioids.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
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Opioid analgesics
Opioid treatment is determined, prescribed, modified and discontinued at the sole discretion of the treating physician at each research site; regardless of generic name, manufacturer, constituent components, route of administration, and dosing schedule (including titration and run-in periods).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
大体时间：After 14-days of opioid treatment
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The absolute and percentage change from baseline in ratings of average pain in the past week at Day 14.
Of note, a percentage change of ≥30% is considered clinically significant.
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After 14-days of opioid treatment
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Improvement of health-related quality of life assessed by QLQ-C30 scores
大体时间：After 14 days of opioid treatment
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The absolute and percentage change from baseline in ratings of health-related quality of life in the past week at Day 14.
A subjectively significant change in QLQ-C30 scores is one that is ≥10 from baseline.
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After 14 days of opioid treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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BPI worst pain in the past week
大体时间：Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI least pain in the past week
大体时间：Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI current pain in the past week
大体时间：Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI pain severity in the past week
大体时间：Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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BPI pain interference score
大体时间：Day 14 post-treatment
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Change from baseline
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Day 14 post-treatment
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Improvement score
大体时间：Day 14 post-treatment
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Proportion with score >4
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Day 14 post-treatment
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Concomitant and rescue medication
大体时间：Until 14 days post-treatment
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Until 14 days post-treatment
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Adverse events
大体时间：Until 14 days post-treatment
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Number (%) of the following:
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Until 14 days post-treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Asbjørn M Drewes, MD, PhD, DMSci、Aalborg University Hospital, Denmark
- 研究主任：Anne E Olesen, MSc (Pharm), PhD、Aalborg University Hospital, Denmark
- 研究主任：Kasper Grosen, MHSc, PhD、Aarhus University / Aarhus University Hospital, Denmark
- 首席研究员：Mogens Pfeiffer-Jensen, MD, PhD、Aarhus University Hospital, Denmark
- 首席研究员：Michael Kamp-Jensen, MD, PhD、Hospitalet Valdemar, Denmark
- 首席研究员：Bart Morlion, MD, PhD、University of Leuven / University Hospitals Leuven, Belgium
- 首席研究员：Gorazd Pozlep, MD、Ljubljana University Medical Centre, Slovenia
- 首席研究员：Torsten Jonsson, MD、Hospitalet Valdemar, Denmark
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年10月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2014年12月2日
首先提交符合 QC 标准的
2014年12月3日
首次发布 (估计)
2014年12月4日
研究记录更新
最后更新发布 (估计)
2016年5月12日
上次提交的符合 QC 标准的更新
2016年5月11日
最后验证
2016年5月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.