Clinical trial NCT00259558: Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
Official title: Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Dose Finding
Phosphatidylcholine
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Prof. Wolfgang Stremmel
name: Dietmar Hopp Stiftung
First posted: 2005-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Eligibility criteria: Inclusion Criteria:

* chronic active ulcerative pancolitis
* course more than 4 months
* clinical index rachmilewitz 7 or more
* endoskopic index 7 or more

Exclusion Criteria:

* steroids in the last 4 weeks
* immunosuppressants in the last 4 weeks
* use of topical klymsa
* pregnancy
* fulminant course
* infectious colitis

Primary outcomes:
measure: Absolute change in clinical activity index (Rachmilewitz).
Secondary outcomes:
measure: Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
measure: Histology and life quality are reported descriptively.
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Medical Hospital Unversity Heidelberg
Study officials:
affiliation: University Heidelberg
name: Wolfgang Stremmel, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.