pilot studie gezonde vrijwilligers urinary excretion 5-ASA
Conditions
Interventions
In the 14 weeks study period, volunteers will receive 5-ASA tablets
(Mezavant®) according to the study schedule either once-daily or twice daily.
Daily morning urine spot samples will be obtained an
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age>18 and
Exclusion criteria
Exclusion criteria: Pregnancy, significant co morbidities or co-medication, use of NSAIDs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the reproducibility and variability in the urinary 5-ASA excretion, as measured with HPLC, in healthy volunteers, and to establish urinary 5-ASA cut-off levels for adherence. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is safety in terms of adverse events and rate of discontinuation due to adverse events of using 5-ASA. Daily morning urine samples will be collected and frozen at -20° before analysis. | — |
Countries
Netherlands
Outcome results
None listed