Last reviewed · How we verify

NCT07138326: STAR

Impact on the Absorption of Drugs in Ostomy Patients

Recruiting now Last updated 22 August 2025
What this trial tests

trial testing Monitoring in Stoma Ileostomy in 128 participants. Currently enrolling.

Timeline
18 June 2025
Primary endpoint
31 December 2026
31 December 2026

Quick facts

Lead sponsorWiGeV Klinik Ottakring
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment128
Start date18 June 2025
Primary completion31 December 2026
Estimated completion31 December 2026
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

WiGeV Klinik Ottakring

Who can join

18 and older, any sex, with Stoma Ileostomy or Ileostomy - Stoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Monitoring

Trials testing the same drug.

Other recruiting trials for Stoma Ileostomy

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07138326.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing