MedTrace Logo

Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients

NCT00849368 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-02-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • 01 Studienregister MasterAdmins · UniversitaetsSpital Zuerich

  • Alexander Jetter, MD · Division of Clinical Pharmacology and Toxicology, University Hospital Zürich, 8091 Zürich, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00849368 on ClinicalTrials.gov