Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-25 @ 8:36 AM
Study NCT ID:
NCT00849368
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2008-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Dose-effect Relationship Between Allopurinol, Azathioprine and 6-thioguanine Nucleotide Levels (6-TGN) in Inflammatory Bowel Disease Patients.
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Main Study Objectives:
The study is conducted to
* evaluate the minimal allopurinol and azathioprine doses that, in combination, produce therapeutic 6-TGN levels
* evaluate the safety and tolerability of the different allopurinol/azathioprine dose levels
* assess if concomitant allopurinol affects TPMT activity
* assess the clinical efficacy of concomitant allopurinol-azathioprine therapy in the included patients
The study is conducted to
* evaluate the minimal allopurinol and azathioprine doses that, in combination, produce therapeutic 6-TGN levels
* evaluate the safety and tolerability of the different allopurinol/azathioprine dose levels
* assess if concomitant allopurinol affects TPMT activity
* assess the clinical efficacy of concomitant allopurinol-azathioprine therapy in the included patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: