Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: retarded release phosphatidylcholine

Study type: Interventional

Funder types: Other

Identifiers

NCT00259558

BFARM - 402 2919

EC - L069/2003

PC3

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 16 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind