Impact on the Absorption of Drugs in Ostomy Patients

Recruiting

• Conditions: Stoma Ileostomy; Ileostomy - Stoma; Colostomy - Stoma; Absorption; Pharmakokinetic

• Registration Number: NCT07138326
• Lead Sponsor: WiGeV Klinik Ottakring

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-18
• Study First Submitted: 2025-06-20
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

Insurmountable language barrier

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achieved therapeutic serum levels in ostomy patients compared with the therapeutic ranges of the respective pivotal study	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.

Trial Locations

Locations (1)

WiGeV Klinik Ottakring; 🇦🇹 Vienna, Austria