Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients

Phase 1

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Drug: Azathioprine / Allopurinol

• Registration Number: NCT00849368
• Lead Sponsor: University of Zurich

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-02
• Study Start: 2009-01
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-06
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azathioprine / Allopurinol	Azathioprine / Allopurinol	Single arm study: Dose escalations as described.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Quantification of trough concentrations of 6-TGN and 6-MMPN in erythrocytes using HPLC at each dose level.	three times per cycle

Secondary Outcome Measures

Name	Time	Method
Dose escalation: Assessment of the percentage of patients who are in the desired therapeutic range on day 23-25 and on day 26-28 of each dose level.	once per cycle
Efficacy: Change in disease activity score in relationship to the dose level attained.	once per cycle
TPMT activity assessment	once per cycle
Safety and Tolerability: Medical history, adverse events and well-being; laboratory screen, physical examination, vital functions: blood pressure, heart rate, body temperature	screening, up to three times per cycle, follow-up

Trial Locations

Locations (1)

Division of Clinical Pharmacology and Toxicology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland