NCT02625155Unknown4 期
Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens: SPHERE
InSource Diagnostics2 个研究点 分布在 1 个国家目标入组 14,000 人开始时间: 2015年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 14,000
- 试验地点
- 2
- 主要终点
- The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
研究概览
简要总结
The purpose of this study is to determine whether the addition of selective pharmacogenomic (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced by a reduction in Target Drug-related Adverse Events (TDRAE) over the period following enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 12 years of age or older;
- •Subject or legal representative is able and willing to provide informed consent;
- •Subject has had a TDRAE including ineffective therapeutic response within the last 60 days or is a new patient to the treating healthcare provider's practice;
- •Subject is scheduled for or is planned to be scheduled for UDT, ordered as per the treating healthcare provider's local standard of care;
- •Subject is currently receiving or the subject's treating healthcare provider is considering treatment with at least one target drug listed below and metabolized by one or more genes considered in this study: Amitriptyline, Imipramine, Diazepam, Alprazolam, Codeine, Hydrocodone, Oxycodone, Methadone, Meperidine, Fentanyl and Carisoprodol.
排除标准
- •Prior history of PGx testing for genes specific to any of the target drugs in the past;
- •PGx testing is deemed mandatory in the opinion of the treating healthcare provider;
- •History of liver or renal transplantation;
- •Receiving chronic hemodialysis or peritoneal dialysis;
- •Currently hospitalized or in a long-term care facility;
- •Participation in another clinical trial that would, in the Investigator's opinion, interfere with the conduct of this study;
- •Subject or subject's guardian or advocate is unable to provide an accurate history of the subject's medical history, medications, and symptoms.
研究组 & 干预措施
Standard of Care (SOC Arm)
Other
Standard of Care UDT
干预措施: Urine diagnostic testing as SOC, drug regimen changes per SOC (Other)
Selective PGx Testing (Test Arm)
Other
Standard of Care UDT with selective PGx testing
干预措施: Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results (Other)
结局指标
主要结局
The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment
时间窗: 90 days
次要结局
- Supra-therapeutic response, as determined by the Investigator(90 days)
- Healthcare resource utilization, as measured by the number of outpatient clinic visits, emergency room/urgent care visits, and hospitalizations; tabulated over the 90-day period following enrollment(90 days)
- Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event(90 days)
- All TDRAE as quantified within each of the four classes of medications(90 days)
- TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug)(90 days)
- Ineffective therapeutic response, determined by the Investigator(90 days)
- Frequency of subjects with changes in drug regimen(90 days)
研究者
研究点 (2)
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