Actively Recruiting
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
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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
Eligibility Criteria
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
You will not qualify if you...
- Insurmountable language barrier
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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