NCT00849368

Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients

Dose-effect Relationship Between Allopurinol, Azathioprine and 6-thioguanine Nucleotide Levels (6-TGN) in Inflammatory Bowel Disease Patients.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Azathioprine / Allopurinol	Both drugs are applied orally. A pre-specified dose escalation regimen will be chosen. Azathioprine: Imurek (R) 50 mg and 25 mg tablets Allopurinol: Mephanol (R) 100 mg tablets

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-02-23
• Last updated: 2012-02-07

Locations

1 site across 1 country: Switzerland