跳至主要内容
临床试验/NCT07138326
NCT07138326招募中不适用

Beeinflussung Der Resorption Von Arzneimitteln Bei Stoma Patient*Innen

WiGeV Klinik Ottakring1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年6月18日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128
试验地点
1
主要终点
Achieved therapeutic serum levels in ostomy patients compared with the therapeutic ranges of the respective pivotal study

研究概览

简要总结

Peroral administration is the preferred way of taking medication. However, the special absorption conditions in ostomy patients are generally not addressed in approval studies and there is also little other literature on this topic. These are usually case reports or studies on individual patients or very small patient collectives.

For medications with measurable clinical parameters, e.g. blood pressure, blood sugar, etc: Blood pressure, blood sugar, etc., these can be used to draw conclusions about any absorption problems. For medications without the possibility of a direct and objective assessment, the assessment is difficult due to the very low level of evidence. Drug groups without a direct physiological measure are e.g: Psy-chotropic drugs (antipsychotics, antidepressants, anxiolytics) and also the novel oral anticoagulants (NOACs).

The clinical trial´s results will answer the following questions:

  • Are therapeutic blood levels of psychotropic drugs and NOACs achieved in ostomy patients when taken orally in the usual way?
  • Are there differences between the measured levels of ileostomy and colostomy patients? Colostomy and ileostomy patients undergoing inpatient or outpatient treatment at the Klinik Ottakring are ready for inclusion. The blood samples will be obtained during medically indicated and performed blood draws within the scope of medical practice, so that no study-associated risks arise here.

Recorded and evaluated:

  • Relevant patient data
  • Plasma levels of the drugs under investigation in ostomy patients. The therapeutic range specified in the respective approval studies serves as the reference value. The results obtained are documented, evaluated and interpreted in an appropriate manner.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Insurmountable language barrier

结局指标

主要结局

Achieved therapeutic serum levels in ostomy patients compared with the therapeutic ranges of the respective pivotal study

时间窗: 18 month

During a routine blood draw, an additional 2ml (Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine)or 3.5 ml (NOACs: edoxaban, rivaroxban, apixaban)of blood is taken. In this sample, the drug levels are determined using a validated method ( LC-MS/MS (Psychotropic drugs) or chromogenic test (NOACs)). The drug level \[µg/ml\] determined in this way is compared with the therapeutic target range specified in the respective approval studies.

次要结局

未报告次要终点

研究者

发起方
WiGeV Klinik Ottakring
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Impact on the Absorption of Drugs in Ostomy Patients | 临床试验