NCT07138326 Impact on the Absorption of Drugs in Ostomy Patients
| NCT ID | NCT07138326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | WiGeV Klinik Ottakring |
| Condition | Stoma Ileostomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 128 participants in total. It began in 2025-06-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Peter Gläser, Dr
STUDY CHAIR
WiGeV Klinik Ottakring
Frequently Asked Questions
Who can join the NCT07138326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stoma Ileostomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07138326 currently recruiting?
Yes, NCT07138326 is actively recruiting participants. Contact the research team at irene.lagoja@gesundheitsverbund.at for enrollment information.
Where is the NCT07138326 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07138326 clinical trial?
NCT07138326 is sponsored by WiGeV Klinik Ottakring. The principal investigator is Peter Gläser, Dr at WiGeV Klinik Ottakring. The trial plans to enroll 128 participants.