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RecruitingNCT07138326STARUpdated Aug 22, 2025

Impact on the Absorption of Drugs in Ostomy Patients

An observational study in Stoma Ileostomy, Ileostomy - Stoma and Colostomy - Stoma, sponsored by WiGeV Klinik Ottakring. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by WiGeV Klinik Ottakring · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
128
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Stoma Ileostomy
  • Ileostomy - Stoma
  • Colostomy - Stoma
  • Absorption
  • Pharmakokinetic
03

In context

Lead sponsor

This is the only study on the registry with WiGeV Klinik Ottakring as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
128 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testMonitoring

    Monitoring

06

What researchers measure

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.

    Time frame: 18 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07138326
Lead sponsor
WiGeV Klinik Ottakring
Responsible party
Sponsor
First posted
Aug 22, 2025
Start date
Jun 18, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 22, 2025

Study contacts

Irene Lagoja, Dr
Contact
irene.lagoja@gesundheitsverbund.at
+431491505508
Stefanie Hehenberger, Mag
Contact
stefanie.hehenberger@gesundheitsverbund.at
+431491505508
Peter Gläser, Dr
study chair · WiGeV Klinik Ottakring

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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