Impact on the Absorption of Drugs in Ostomy Patients

NCT ID: NCT07138326

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2026-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Monitoring

Monitoring

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WiGeV Klinik Ottakring

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Gläser, Dr

Role: STUDY_CHAIR

WiGeV Klinik Ottakring

Locations

WiGeV Klinik Ottakring

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Irene Lagoja, Dr

Role: CONTACT

irene.lagoja@gesundheitsverbund.at

+431491505508

Stefanie Hehenberger, Mag

Role: CONTACT

stefanie.hehenberger@gesundheitsverbund.at

+431491505508

Facility Contacts

Irene Lagoja, Dr

Role: primary

irene.lagoja@gesundheitsverbund.at

+431491505508

Other Identifiers

EK25008

Identifier Type: -

Identifier Source: org_study_id