Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazine

• Conditions: lcerative colitis

• Registration Number: EUCTR2010-018557-35-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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: Interventional clinical trial of medicinal product
• Study Design: Not specified