Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa
Sponsor study identifier
Secondary identifiers
interventional
60
1 country
1
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
November 25, 2005
Actual (reported)November 29, 2005
Actual (reported)March 2006
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Medical Hospital Unversity Heidelberg
Heidelberg, 69120, Germany
Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. doi: 10.1136/gut.2004.052316.
Stremmel W, Braun A, Hanemann A, Ehehalt R, Autschbach F, Karner M. Delayed release phosphatidylcholine in chronic-active ulcerative colitis: a randomized, double-blinded, dose finding study. J Clin Gastroenterol. 2010 May-Jun;44(5):e101-7. doi: 10.1097/MCG.0b013e3181c29860.
Wolfgang Stremmel, Professor
University Heidelberg
First Submitted
November 25, 2005
First Posted
November 29, 2005
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
March 2006
Date type not reportedMulti-center, single-arm, phase II clinical trial evaluating efficacy and in-vivo homing of adoptively transferred autologous ex-vivo expanded regulatory T cells in adults with ulcerative colitis
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
February 12, 2007
Record last verified: 2007-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: