Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study

• 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
• 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
• Affiliation: Meander Medical Center

• Name: SF Chavoushi
• 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)

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)

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

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