MedTrace Logo

Impact on the Absorption of Drugs in Ostomy Patients

NCT07138326 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2025-08-22

No results posted yet for this study

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

  • Ileostomy - Stoma
  • Colostomy - Stoma
  • Absorption
  • Pharmakokinetic
  • Stoma Ileostomy

Interventions

DIAGNOSTIC_TEST

Monitoring

Monitoring

Sponsors & Collaborators

  • WiGeV Klinik Ottakring

    lead OTHER

Principal Investigators

  • Peter Gläser, Dr · WiGeV Klinik Ottakring

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07138326 on ClinicalTrials.gov