Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00259545

Enrollment

Registered

2005-11-29

Start date

2003-02-28

Completion date

2006-02-28

Last updated

2008-06-05

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

Conditions

Phosphatidylcholine, Ulcerative Colitis

Keywords

retarded phosphatidylcholine, chronic active, steroid

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 Crohn´s 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 Jul;54(7):966-71. 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

Interventions

DRUGRetarded Release Phosphatidylcholine (rPC)

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

* Signed Letter of Content * diagnosis of ulcerative colitis (clinical, endoscopic and histologic evidence) * chronic active and steroid dependent course over at least 4 months (CAI \> 4, EAI \> 4)

Exclusion criteria

* infectious colitis * toxic megacolon * ulcerative proctitis or less than 20cm inflamed

Design outcomes

Primary

Measure	Time frame
complete steroid reduction	—

Secondary

Measure	Time frame
remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026