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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 July 2015
Main ID:  EUCTR2013-001503-37-DK
Date of registration: 06/05/2013
Prospective Registration: Yes
Primary sponsor: Marianne Kiszka-Kanowitz
Public title: Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease
Scientific title: Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease
Date of first enrolment: 31/05/2013
Target sample size: 46
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001503-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Azathioprine compared to low dose Azathioprine and Allopurinol Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Denmark
Contacts
Name: Marianne Kiszka-Kanowitz   
Address:  Kettegård Allé 30 2650 Hvidovre Denmark
Telephone:
Email: marianne.kiszka-kanowitz@regionh.dk
Affiliation:  Hvidovre Hospital
Name: Marianne Kiszka-Kanowitz   
Address:  Kettegård Allé 30 2650 Hvidovre Denmark
Telephone:
Email: marianne.kiszka-kanowitz@regionh.dk
Affiliation:  Hvidovre Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
• All subjects must give written informed consent.
• Male or female subjects, between the ages of 18 and 80.
• Subjects with Ulcerative colitis and Crohn’s disease that according to the treatment guidelines in the department is recommended treatment with AZA.
• UC and CD diagnosed by known criteria.
• Normal TPMT, phenotype =14

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
• Kidney failure, creatinine >120 mmol/L
• Elevated liverenzymes (ALAT)
• Infection with clostridium dificile
• Participation in other medication trials



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Inflammatory Bowel Disease, (Ulcerativ colitis, Crohns disease)
MedDRA version: 14.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Imurel
Pharmaceutical Form: Tablet
INN or Proposed INN: azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Allopurinol
Pharmaceutical Form: Tablet
INN or Proposed INN: allopurinol
CAS Number: 17795-21-0
Other descriptive name: ALLOPURINOL SODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: The aim of this study is to compare clinical remission rate and rate of adverse drug effect in IBD patients with normal TPMT treated with conventional AZA therapy compared to combination therapy with ALLO and low dose AZA.
Primary end point(s): To compare the proportion of patients with IBD in clinical remission according to Mayo or Harvey-Bradshaw index (HBi) after treatment with AZA or AZA and ALLO at week 8, 12 and 24.

Secondary Objective: not applicable
Timepoint(s) of evaluation of this end point: week 8, 12 and 24
Secondary Outcome(s)
Secondary end point(s): • To compare adverse effects to the treatment after 8, 12 and 24 weeks in the two groups.
• To compare calprotectin levels after 4, 8, 12 and 24 weeks in the two groups.
• To compare quality of life after 8, 12 and 24 weeks in the two groups.
• To compare the proportion of patients with clinical response at week 8, 12 and 24
Timepoint(s) of evaluation of this end point: week 8, 12 and 24.
Secondary ID(s)
AZA/allo/v2.29.03.2013
Source(s) of Monetary Support
Hvidovre Hospital
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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