Condition category
Digestive System
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
16/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr K.H.N. de Boer

ORCID ID

Contact details

Gastroenterology & Hepatology
VU Medical Centre
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
KHN.deBoer@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR109

Study information

Scientific title

Acronym

5-ASA-AZA

Study hypothesis

5-Aminosalicylates influence the metabolism of thiopurines leading to higher levels of the pharmacological end-metabolite 6-thioguaninenucleotides

Ethics approval

Ethics approval received from local medical ethics committees

Study design

Multicentre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

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 names

5-Aminosalicylates

Primary outcome measures

The rise or fall in thiopurine metabolite levels

Secondary outcome measures

Safety

Overall trial start date

01/07/2005

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Steady state thiopurine therapy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

24

Participant exclusion criteria

1. Active disease
2. Comedication that may influence thiopurine metabolism
3. Pregnancy/lactation

Recruitment start date

01/07/2005

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Gastroenterology & Hepatology
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Gastroenterology and Hepatology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Gastroenterology and Hepatology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes