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

Phase 1

Conditions: Crohn's disease & Colitis Ulcerosa
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-001638-84-NL

Lead Sponsor: Meander Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ;Secondary Objective: -Comparing patient tolerability in terms of adverse events<br>-comparing allopurinol concentrations<br>-comparing enzyme activity for XO, TPMT and HRPT<br>-comparing disease activity scores (CDAI and MAYO) ;Primary end point(s): 6-TGN and 6-MMP concentrations;Timepoint(s) of evaluation of this end point: Right before and one month after the intervention

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Frequency and incidence adverse events<br>-Allopurinol concentrations<br>-Enzyme activity XO, TPMT and HPRT<br>-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