The influence of 5-aminosalicylates in thiopurine metabolite levels
| ISRCTN | ISRCTN71092125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71092125 |
| Protocol serial number | NTR109 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Gastroenterology and Hepatology |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 16/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr K.H.N. de Boer
Scientific
Scientific
Gastroenterology & Hepatology
VU Medical Centre
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| KHN.deBoer@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | 5-ASA-AZA |
| Study objectives | 5-Aminosalicylates influence the metabolism of thiopurines leading to higher levels of the pharmacological end-metabolite 6-thioguaninenucleotides |
| Ethics approval(s) | Ethics approval received from local medical ethics committees |
| Health condition(s) or problem(s) studied | Inflammatory bowel disease, ulcerative colitis, Crohn's disease |
| Intervention | Co-administration of 5-ASA (2 g/4 g/0 g followed by frequent blood draws. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-Aminosalicylates |
| Primary outcome measure(s) |
The rise or fall in thiopurine metabolite levels |
| Key secondary outcome measure(s) |
Safety |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 24 |
| Key inclusion criteria | Steady state thiopurine therapy |
| Key exclusion criteria | 1. Active disease 2. Comedication that may influence thiopurine metabolism 3. Pregnancy/lactation |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Gastroenterology & Hepatology
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
