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5-ASA-AZA study.


- candidate number1174
- NTR NumberNTR109
- ISRCTNISRCTN90526229
- Date ISRCTN created12-sep-2005
- date ISRCTN requested18-aug-2005
- Date Registered NTR3-aug-2005
- Secondary IDsN/A 
- Public Title5-ASA-AZA study.
- Scientific TitleThe influence of 5-aminosalicylates in thiopurine metabolite levels.
- ACRONYM5-ASA-AZA
- hypothesis5-Aminosalicylates influence the metabolism of thiopurines leading to higher levels of the pharmacological end-metabolite 6-thioguaninenucleotides.
- Healt Condition(s) or Problem(s) studiedInflammatory bowel disease, Crohn's disease, Ulcerative Colitis
- Inclusion criteriaSteady state thiopurine therapy.
- Exclusion criteria1. Active diseas;
2. Comedication that may influence thiopurine metabolism;
3. Pregnancy/lactation.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-jul-2005
- planned closingdate1-jan-2006
- Target number of participants24
- InterventionsCo-administration of 5-ASA (2 gram/4 gram/0 gram) followed by frequent blood draws.
- Primary outcomeThe rise or fall in thiopurine metabolite levels.
- Secondary outcomeSafety.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES K.H.N. Boer, de
- CONTACT for SCIENTIFIC QUERIES K.H.N. Boer, de
- Sponsor/Initiator VU University Medical Center, Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Department of Gastroenterology and Hepatology
- PublicationsN/A
- Brief summaryIBD patients on steady state thiopurine receive three regimes of 5-ASA. During these periods blood will be drawn on set times to evaluate the metabolite levels.
- Main changes (audit trail)
- RECORD4-aug-2005 - 16-okt-2008


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