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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: 23 October 2017
Main ID:  EUCTR2016-001638-84-NL
Date of registration: 17/05/2016
Prospective Registration: Yes
Primary sponsor: Meander Medical Center
Public title: Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study
Scientific title: Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study - ThiLDA-study
Date of first enrolment: 08/07/2016
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001638-84
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Netherlands
Contacts
Name: SF Chavoushi   
Address:  Maatweg 3 3813 TZ Amersfoort Netherlands
Telephone: 0031612928800
Email: faraz.chavoushi@gmail.com
Affiliation:  Meander Medical Center
Name: SF Chavoushi   
Address:  Maatweg 3 3813 TZ Amersfoort Netherlands
Telephone: 0031612928800
Email: faraz.chavoushi@gmail.com
Affiliation:  Meander Medical Center
Key inclusion & exclusion criteria
Inclusion criteria:
-Crohn's disease or Colitis Ulcerosa
-At least one month perior usage of 100 mg allopurinol daily with azathioprine or mercaptopurine
-at least 18 years old
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
-Age below 18 years old


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's disease & Colitis Ulcerosa
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Allopurinol Sandoz 100 mg, tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: ALLOPURINOL
CAS Number: 315-30-0
Current Sponsor code: allopurinol
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: ALLOPURINOL
CAS Number: 315-30-0
Current Sponsor code: allopurinol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: Investigating whether 50 mg allopurinol is non-inferior to 100 mg in combination with azathioprine or mercaptopurine by measuring and comparing thiopurine metabolites
Primary end point(s): 6-TGN and 6-MMP concentrations
Secondary Objective: -Comparing patient tolerability in terms of adverse events
-comparing allopurinol concentrations
-comparing enzyme activity for XO, TPMT and HRPT
-comparing disease activity scores (CDAI and MAYO)
Timepoint(s) of evaluation of this end point: Right before and one month after the intervention
Secondary Outcome(s)
Secondary end point(s): -Frequency and incidence adverse events
-Allopurinol concentrations
-Enzyme activity XO, TPMT and HPRT
-Disease activity scores (CDAI for Crohn's and Mayo for Colitis Ulcerosa)
Timepoint(s) of evaluation of this end point: Right before and one month after the intervention
Secondary ID(s)
16-07
Source(s) of Monetary Support
Meander Medical Center
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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