Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease

• Register: EUCTR
• Last refreshed on: 10 August 2021
• 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: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: Marianne Kiszka-Kanowitz
• Affiliation: Hvidovre Hospital

• Name: Marianne Kiszka-Kanowitz
• 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)

Secondary Objective: not applicable

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.

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

Ethics review

Status: Approved
Approval date: 31/05/2013
Contact: