NCT02096172撤回不适用
Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA
Renaissance RX0 个研究点开始时间: 2014年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Influence of CYP450 drug metabolism on quantitative UDT
研究概览
简要总结
The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Able to provide written informed consent
- •Pharmacogenomic testing within the last 60 days
- •Planned UDT
排除标准
- •Subject has chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5
- •Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST or ALT >1.5x normal, or suspected cirrhosis)
- •Subject has a history of malabsorption (short gut syndrome);
- •Subject has a history of any gastric or small bowel surgery;
- •Subject is currently hospitalized;
- •Subject is currently receiving intravenous medication.
结局指标
主要结局
Influence of CYP450 drug metabolism on quantitative UDT
时间窗: 24 months
Occurrence of genetically-determined abnormal metabolism of drugs tested with UDT, classified as genetic effects on metabolism (GEM) + for rapid metabolizers, GEM 0 for normal metabolizers, and GEM - for slow metabolizers.
次要结局
- Non-prescribed drugs detected on UDT and the GEM classification associated with these medications(24 months)
- Occurrence of illicit drugs detected on UDT and the GEM classification associated with these medications(24 months)
- Frequency of target drug regimen changes by the treating physician due to pharmacogenomic test results(24 months)
- False positive immunoassay results, defined as positive immunoassay concurrent with negative quantitative testing(24 months)
- Frequency of illicit drug changes by the subject due to UDT results, as observed at the time of repeat UDT(24 months)
- Frequency of non-prescribed drug changes by the subject due to UDT results, as detected at the time of repeat UDT(24 months)
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