Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment.
Phase 4
Completed
- Conditions
- ulcerative colitis1001796910001708
- Registration Number
- NL-OMON34817
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Age> 18 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
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The results will be shown in percentages of patients with successful<br /><br>desensitization. Furthermore percentages will be shown of patients with<br /><br>reproducible symptoms to earlier reactions during clinical re-challenge<br /><br>procedure. </p><br>
- Secondary Outcome Measures
Name Time Method <p>describe pattern of intolerance</p><br>