Measuring 5-ASA urinary excretion levels in healthy volunteers
- Conditions
- pilot studie gezonde vrijwilligersurinary excretion 5-ASA
- Registration Number
- NL-OMON36986
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Age>18 and <80 years and no significant co morbidities or co-medication
Exclusion Criteria
Pregnancy, significant co morbidities or co-medication, use of NSAIDs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is the reproducibility and variability in the urinary 5-ASA<br /><br>excretion, as measured with HPLC, in healthy volunteers, and to establish<br /><br>urinary 5-ASA cut-off levels for adherence. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome is safety in terms of adverse events and rate of<br /><br>discontinuation due to adverse events of using 5-ASA. Daily morning urine<br /><br>samples will be collected and frozen at -20° before analysis. </p><br>