Actively Recruiting

Age: 18Years +
All Genders
ID07138326

Impact on the Absorption of Drugs in Ostomy Patients Observational Study by WiGeV Klinik Ottakring

Led by WiGeV Klinik Ottakring · Updated on 2025-08-22

128

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how drugs are absorbed in patients with ostomies, focusing on psychotropic drugs and novel oral anticoagulants (NOACs). These drugs' absorption is not well understood in ostomy patients, as previous studies often involve only small groups or case reports. The study aims to find out if therapeutic blood levels are reached when these medications are taken orally by ileostomy and colostomy patients. This observational trial monitors drug levels by collecting blood samples during routine medical care, avoiding additional risks to participants. The study compares measured drug levels in ileostomy and colostomy patients to the therapeutic ranges defined in previous approval studies. Relevant patient data and plasma drug levels will be recorded and analyzed to evaluate absorption. Participants will be patients with an ileostomy or colostomy who have been taking specified psychotropic drugs or NOACs for at least seven days. Blood samples taken as part of regular treatment will be used to measure drug levels. The main outcome is whether therapeutic serum concentrations are achieved over an 18-month period. The study is sponsored by WiGeV Klinik Ottakring and involves no extra risks beyond routine care.

CONDITIONS

Brief Title

Impact on the Absorption of Drugs in Ostomy Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 18 years or older
  • Patients with an ileostomy or colostomy created at least 7 days ago
  • Taking at least one of the specified psychotropic drugs or NOACs for at least 7 days
  • Patients must be part of the relevant treatment collective
Not Eligible

You will not qualify if you...

  • Insurmountable language barrier

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 18 months

Participants who undergo routine care are observed to assess drug absorption and achieve therapeutic serum levels.

Visits scheduled according to participant routine care and monitoring needs

Trial Site Locations

Total: 1 location

1

WiGeV Klinik Ottakring

Vienna, State of Vienna, Austria, 1160

Actively Recruiting

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Research Team

I

Irene Lagoja, Dr

S

Stefanie Hehenberger, Mag

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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