INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH (INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH)

概览

疾病领域	数量

感染	1

排名前五的药物类型	数量

诊断用放射药物	1
小分子化药	1

关联

1

项与 INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH 相关的药物

Urea-13C

尿素C-13

靶点-

作用机制

PET imaging

在研机构

Richen Europe S.r.l.初创企业 [+3]

原研机构

Otsuka America Pharmaceutical, Inc.

在研适应症

诊断试剂 [+1]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期1996-09-17

2

项与 INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH 相关的临床试验

EUCTR2017-001369-25-DE / Not yet recruiting临床4期

The Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal with 13C-Urea Breath Test in Helicobacter Pylori Positive and Negative Patients with Dyspepsia and GERD Taking Proton Pump Inhibitors

开始日期2018-03-19

申办/合作机构

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

EUCTR2008-008010-39-DE / Unknown statusN/A

The Sensivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal with 13C-Urea Breath Test in Helicobacter Pylori Positive and Negative Patients with Dyspepsia Taking Proton Pump Inhibitors - PPI Study

开始日期2009-04-23

申办/合作机构

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

100 项与 INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH 相关的临床结果

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0 项与 INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH 相关的专利（医药）

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1

项与 INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH 相关的文献（医药）

2017-01-01·World Journal of Gastroenterology3区 · 医学

Modified Helicobacter test using a new test meal and a ¹³C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors

3区 · 医学

Article

作者: Tepeš, Bojan ; Malfertheiner, Peter ; Labenz, Joachim ; Aygen, Sitke

AIMTo determine the sensitivity and specificity of the ¹³C-urea breath test (UBT) in patients taking proton pump inhibitors (PPIs), using a new test meal Refex.METHODSOne hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori (H. pylori) positive, 49 H. pylori negative, were included in the study. The patients were then given esomeprazole 40 mg for 29 consecutive days, and the ¹³C-UBT with the new test meal was performed the next morning.RESULTSThe sensitivity of the ¹³C-UBT with a cut off 2.5‰ was 92.45% (95%CI: 81.79%-97.91%) by per-protocol (PP) analysis and 78.13% (95%CI: 66.03%-87.49%) by intention-to-treat (ITT) analysis. The specificity of the ¹³C-UBT test was 96.00% in the ITT population (95%CI: 86.29%-99.51%) and 97.96% in the PP population (95%CI: 89.15%-99.95%).CONCLUSIONThe new test meal based ¹³C-UBT is highly accurate in patients on PPIs and can be used in those unable to stop their PPI treatment.

100 项与 INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH 相关的药物交易

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100 项与 INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH 相关的转化医学

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