Ulcerative Colitis
Conditions
Keywords
remission, mesalazin, non-inferiority study, relapse
Brief summary
The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis. The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.
Interventions
2g daily, given orally QTD
Sponsors
Dietmar Hopp Stiftung
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of ulcerative colitis in remission (CAI 3 or less) * signed letter of content * no steroids or immunosupressants in the last 6 weeks * at least 5 relapses in the last 3 years * last relapse was 8 months ago or less * complete colonoscopy at entry
Exclusion criteria
* pregnancy or breast feeding * steroids or immunosuppressants * acute episode of UC * condition after complete or partial colektomy * known intolerance to mesalazin * severe medical disease other than colitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of relapses | — |
| relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| endoscopic index | — |
| histolgical score | — |
| time to the first relapse | — |
| side effects | — |
| life quality | — |
| amount of relapses per year | — |
Countries
Germany
Outcome results
None listed