Impact on the Absorption of Drugs in Ostomy Patients

NCT07138326 | Recruiting

• 1 other identifier: EK25008
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Stoma Ileostomy; Ileostomy - Stoma; Colostomy - Stoma; Absorption; Pharmakokinetic

Outcome Measures

Primary Outcomes (1)

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

  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.

  18 month

Interventions

Monitoring DIAGNOSTIC_TEST

Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ileostomy and colostomy patients undergoing inpatient/outpatient treatment at Klinik Ottakring

You may qualify if:

• 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

You may not qualify if:

• Insurmountable language barrier

Sponsors & Collaborators

• WiGeV Klinik Ottakring: lead

Study Sites (1)

WiGeV Klinik Ottakring

Vienna, Vienna, 1160, Austria

RECRUITING

Study Officials

• Peter Gläser, Dr

  WiGeV Klinik Ottakring

  STUDY CHAIR

Central Study Contacts

Irene Lagoja, Dr

CONTACT

+431491505508; irene.lagoja@gesundheitsverbund.at

Stefanie Hehenberger, Mag

CONTACT

+431491505508; stefanie.hehenberger@gesundheitsverbund.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: August 22, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)