Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259558
Status:
COMPLETED
Last Update Posted:
2007-02-12
First Post:
2005-11-25
Brief Title:
Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Prospektive Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa
Status:
COMPLETED
Status Verified Date:
2007-02
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 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 Crohns 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
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 Crohns 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
Detailed Description:
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
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
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 |
|---|---|---|---|
| EC - L0692003 | None | None | None |
| BFARM - 402 2919 | None | None | None |