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NCT07138326: STAR
Impact on the Absorption of Drugs in Ostomy Patients
trial testing Monitoring in Stoma Ileostomy in 128 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | WiGeV Klinik Ottakring |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 128 |
| Start date | 18 June 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Monitoring
Conditions studied
- Stoma Ileostomy — all drugs for Stoma Ileostomy →
- Ileostomy - Stoma — all drugs for Ileostomy - Stoma →
- Colostomy - Stoma — all drugs for Colostomy - Stoma →
- Absorption — all drugs for Absorption →
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:
- PubMed search for NCT07138326
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Stoma Ileostomy
Currently open trials in the same condition.
- NCT07376421 — Clinical Investigation Exploring a Newly Developed Ostomy Baseplate · NA · recruiting
- NCT06461559 — Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion · Phase 1, PHASE2 · recruiting
- NCT06554015 — Prospective Longitudinal Study of Heylo™ for People Living With a Stoma · recruiting
- NCT06458699 — Management Of Stoma In Patients Younger Than 3 Months Old · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07138326 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by WiGeV Klinik Ottakring
- Last refreshed: 22 August 2025
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