Research with human participants

Overview of medical research in the Netherlands

5-ASA-AZA study.

No registrations found.

Download: PDF | XML
Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON27677

Source

NTR

Brief title

5-ASA-AZA

Health condition

inflammatory bowel disease, crohn's disease and ulcerative colitis

Sponsors and support

Primary sponsor :
investigator initiated
Source(s) of monetary or material Support :
-

Intervention

Outcome measures

Primary outcome

The rise or fall in thiopurine metabolite levels.

Secondary outcome

Safety.

Background summary

IBD 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.

Study objective

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

Intervention

Co-administration of 5-ASA (2 gram/4 gram/0 gram) followed by frequent blood draws.

Public
VU University Medical Center, Department of Gastroenterology and Hepatology,
P.O. Box 7057
K.H.N. Boer, de
Amsterdam 1007 MB
The Netherlands
KHN.deBoer@vumc.nl
Scientific
VU University Medical Center, Department of Gastroenterology and Hepatology,
P.O. Box 7057
K.H.N. Boer, de
Amsterdam 1007 MB
The Netherlands
KHN.deBoer@vumc.nl

Inclusion criteria

Steady state thiopurine therapy.

Exclusion criteria

1. Active diseas;

2. Comedication that may influence thiopurine metabolism;

3. Pregnancy/lactation.

Design

Study type :
Interventional
Intervention model
:
Other
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
24
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL78
NTR-old NTR109
Other : N/A
ISRCTN ISRCTN90526229

Summary results

N/A