Drug absorption in people with an ostomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational monitoring project at a single center in Vienna that follows adults with an ileostomy or colostomy who have had their stoma for at least seven days. Participants must have been taking one or more specified psychotropic drugs or a NOAC for at least seven days, and the team will use blood tests and, where applicable, clinical measures (for example blood pressure or blood sugar) to determine absorption. The goal is to determine whether therapeutic drug levels are achieved in ostomy patients, addressing a gap left by approval studies and limited case reports. Results will help clarify whether dosing or monitoring practices should differ for people with stomas.

Why it matters

Who can join: the full rules

Planned inclusion criteria:

* Male and female patients aged ≥18 years
* Belonging to a collective
* Ileostomy since ≥7d
* Colostomy since ≥7d The stoma must have been inserted at least 7d ago to ensure that a steady state concentration is achieved.
* Taking ≥1 of the following active substances since ≥7d:

  * Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine
  * NOACs: edoxaban, rivaroxban, apixaban

Exclusion Criteria:

Insurmountable language barrier

Where it's running

• WiGeV Klinik Ottakring
  Vienna, State of Vienna, Austria Recruiting

Study contacts

• Study coordinator: Irene Lagoja, Dr
• Email: irene.lagoja@gesundheitsverbund.at
• Phone: +431491505508

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.