Actively Recruiting

Age: 18Years +
All Genders
NCT07138326

Impact on the Absorption of Drugs in Ostomy Patients

Led by WiGeV Klinik Ottakring · Updated on 2025-08-22

128

Participants Needed

1

Research Sites

80 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Impact on the Absorption of Drugs in Ostomy Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 18 years or older
  • Ileostomy present for at least 7 days
  • Colostomy present for at least 7 days
  • Taking at least one of the following medications for 7 days or more: psychotropic drugs (such as citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine) or novel oral anticoagulants (edoxaban, rivaroxaban, apixaban)
Not Eligible

You will not qualify if you...

  • Insurmountable language barrier

AI-Screening

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Trial Site Locations

Total: 1 location

1

WiGeV Klinik Ottakring

Vienna, State of Vienna, Austria, 1160

Actively Recruiting

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Research Team

I

Irene Lagoja, Dr

CONTACT

S

Stefanie Hehenberger, Mag

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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