Crohn's disease & Colitis Ulcerosa
Conditions
Interventions
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(
Sponsors
Meander Medical Center
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: -Age below 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 -comparing allopurinol concentrations -comparing enzyme activity for XO, TPMT and HRPT -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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Contacts
Public ContactSF Chavoushi
Meander Medical Center
Outcome results
None listed