Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259545
Status:
COMPLETED
Last Update Posted:
2008-06-05
First Post:
2005-11-25
Brief Title:
Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Prospektive Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis
The hypothesis is that ulcerative colitis is caused by a barrier defect of the colonic mucus layer The background of the study is the finding that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis UC compared to healthy controls and patients with Crohns disease The content was measured in non-inflamed areas of the colon in UC Thus we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC See Gut 2005 Jul547966-71 Stremmel et al
The hypothesis is that ulcerative colitis is caused by a barrier defect of the colonic mucus layer The background of the study is the finding that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis UC compared to healthy controls and patients with Crohns disease The content was measured in non-inflamed areas of the colon in UC Thus we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC See Gut 2005 Jul547966-71 Stremmel et al
Detailed Description:
Design Prospective randomized placebo-controlled double-blinded study
Population 60 patients with chronic active ulcerative colitis and steroid dependency
Inclusion Chronic active ulcerative colitis clinical index 5 or more endoscopic Index 5 or more steroid dependent course since at least 4 months
Main criteria complete steroid reduction
Population 60 patients with chronic active ulcerative colitis and steroid dependency
Inclusion Chronic active ulcerative colitis clinical index 5 or more endoscopic Index 5 or more steroid dependent course since at least 4 months
Main criteria complete steroid reduction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BFARM - 402 29 17 | None | None | None |
| EC - L712003 | None | None | None |