A Phase 2 interventional study of retarded release phosphatidylcholine in Ulcerative Colitis, sponsored by Heidelberg University. Completed at 1 site in Germany. Open to participants aged 16 Years to 90 Years. Per ClinicalTrials.gov, last updated 2007-02-12.
Sponsored by Heidelberg University · Phase 2, Interventional, and Treatment
The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine in the most severe form of ulcerative colitis.
The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.
Design: prospective, randomized, double-blind, dose-finding study with retarded phosphatidylcholine.
Population: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to historic groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at least 7 or more. No systemic steroids or immunosuppressants since 4 weeks.
Exclusion criteria: Pregnancy \& fulminant course
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Absolute change in clinical activity index (Rachmilewitz).
Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
Histology and life quality are reported descriptively.
This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.
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Heidelberg University