Ulcerative colitis
Conditions
Interventions
Trade Name: Mesalazine
Product Name: Mesalazine
Product Code: Salofalk
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age> 16 years. 2. History of ulcerative colitis (active or in remission). 3. Presumed history of intolerance (diarrhea, urticaria, fever, acute pancreatitis or elevated c-reactive protein) for any 5-ASA drugs. 4. Informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of intolerance with the following reactions; interstitial nephritis, anaphylactic shock or bullous skin reations. 2. Pregnancy or fertile women without adequate anticonception. 3. Renal dysfunction (diminished eGFR <40ml/min) 4. Poor mental health. 5. No informed consent. 6. Non compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether patients with known intolerance for mesalazine, can be desensitizied for mesalazine.;Secondary Objective: To investigate if a presumed history of intolerance will be reproducible in a clinical setting.;Primary end point(s): 1. Successful desensitization for mesalazine in patients with a presumed history of intolerance for mesalazine. | — |
Countries
Netherlands
Outcome results
None listed