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临床试验/NCT05259865
NCT05259865暂停不适用

The Utility of Genetic Testing in Predicting Drug Response in Chronic Pain

Canadian Forces Health Services Centre Ottawa1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
400
试验地点
1
主要终点
Sensitivity and Specificity of PGx testing for pain response

研究概览

简要总结

Understanding the impact of genetics could aid rational, precision drug choices. In the current study, investigators will focus on whether genetic analysis of drug processing using the Inagene platform could predict efficacy and side effect profile in patients prescribed medication for pain.

详细描述

Understanding the impact of genetics could aid rational, precision drug choices. In the current study, investigators will focus on whether genetic analysis of drug processing using the Inagene platform could predict efficacy and side effect profile in patients prescribed medication for pain. In the investigator's clinic commonly employed medications included nortriptyline, duloxetine, topiramate, gabapentin, pregabalin, opioids (morphine derivatives, tramadol, tapentadol, buprenorphine patch), cesamet (a synthetic cannabinoid). To the investigator's knowledge this type of study has not been completed in this environment and/or patient population.

Research Objectives:

The main goal of this study is to determine whether genetic analysis of drug processing could help predict efficacy and side effect profiles of medications in a cohort of patients suffering from chronic pain.

In order to control for various clinical factors, patient reported outcomes will also be collected. As a standard part of any patient intake, pain diagrams, measures of pain, function, mental health status and exercise describe the conditions and relative impact will be included. Investigators will include various standardized and/or adapted versions of other questionnaires which will allow investigators to control for known confounders.

The following information will be collected at baseline

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • male and female between 18 and 60 years old
  • seen within the CFO-P
  • diagnosed by a physician with one or more chronic pain condition.

排除标准

  • adults who are unable to give their own consent
  • contraindications to a buccal swab
  • uncontrolled mental health issues determined by clinical judgement without mental health treatment and/or presence of active suicidal ideation

结局指标

主要结局

Sensitivity and Specificity of PGx testing for pain response

时间窗: up to 8 weeks post initial medication prescription

For the main analysis, the phenotypes will be grouped 1\&2 (do not prescribe) and 3\&4 (prescribe) and compared against whether patient responded or not to determine sensitivity and specificity of the genetic testing. Sub-analysis will determine for those that did not respond and whether this was a result of side effects or a lack of efficacy

次要结局

  • Sensitivity and Specificity of PGx testing for side effects(up to 8 weeks post initial medication prescription)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gaurav Gupta

Principal Investigator

Canadian Forces Health Services Centre Ottawa

研究点 (1)

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