Condition category
Digestive System
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
27/02/2007
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

Dr K H N de Boer

ORCID ID

Contact details

VU University Medical Centre
Department of Gastroenterology and Hepatology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
KHN.deBoer@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Oral 6-thioguanine (6TG) results in a high intra-hepatic exposure to 6TG generated metabolites.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Non-randomised, non-controlled, clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Irritable Bowel Syndrome (IBS), Ulcerative colitis, Crohn's Disease

Intervention

Patients will receive both 6TG orally and intravenously. On set times (for eight hours) blood will be drawn to determine the concentrations of different metabolites and enzymes.

Intervention type

Drug

Phase

Not Specified

Drug names

6-thioguanine

Primary outcome measures

Determination of first pass effect of 6TG metabolites.

Secondary outcome measures

Determination of influence of different enzymes on 6TG metabolism.

Overall trial start date

01/06/2005

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Irritable Bowel Disease (IBD)
2. In need of immunosuppressants
3. Intolerant to azathioprine or methotrexate

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

16

Participant exclusion criteria

1. Concomitant use of drugs interfering with thiopurine metabolism
2. Pregnancy/lactation

Recruitment start date

01/06/2005

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/

Funders

Funder type

Hospital/treatment centre

Funder name

VU University Medical Centre (VUMC) (The Netherlands)

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