Completed

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

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What is being tested

Azathioprine / Allopurinol

Drug
Who is being recruted

Digestive System Diseases+2

+ Gastroenteritis

+ Gastrointestinal Diseases

From 18 to 65 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2009
See protocol details

Summary

Principal SponsorUniversity of Zurich
Last updated: January 27, 2026
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Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

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

Official TitleDose-effect Relationship Between Allopurinol, Azathioprine and 6-thioguanine Nucleotide Levels (6-TGN) in Inflammatory Bowel Disease Patients.
NCT00849368
Principal SponsorUniversity of Zurich
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

7 inclusion criteria required to participate
Able and willing to give written informed consent before any trial-specific procedures are performed
Signed informed consent form
Age 18 to 65 years at study entry
Body Mass Index 18 - 30 kg/m2
Show More Criteria
23 exclusion criteria prevent from participating
Subjects with confirmed or suspected hypersensitivity towards the study medication
Contemporaneous participation in any other study
Females only: pregnancy
Females only: breast-feeding
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Single arm study: Dose escalations as described.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Division of Clinical Pharmacology and Toxicology, University Hospital Zurich

Zurich, SwitzerlandOpen Division of Clinical Pharmacology and Toxicology, University Hospital Zurich in Google Maps
CompletedOne Study Center