Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00259558

Enrollment

Registered

2005-11-29

Start date

2003-04-30

Completion date

2006-03-31

Last updated

2007-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis, Dose Finding, Phosphatidylcholine

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

Interventions

DRUGretarded release phosphatidylcholine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Absolute change in clinical activity index (Rachmilewitz).	—

Secondary

Measure	Time frame
Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).	—
Histology and life quality are reported descriptively.	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026