Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

NCT ID: NCT00259558

Last Updated: 2007-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2006-03-31

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

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

retarded release phosphatidylcholine

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Wolfgang Stremmel

UNKNOWN

Sponsor Role: collaborator

Dietmar Hopp Stiftung

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Principal Investigators

Wolfgang Stremmel, Professor

Role: PRINCIPAL_INVESTIGATOR

University Heidelberg

Locations

Medical Hospital Unversity Heidelberg

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 15951544 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20048683 (View on PubMed)

Other Identifiers

EC - L069/2003

Identifier Type: -

Identifier Source: secondary_id

BFARM - 402 2919

Identifier Type: -

Identifier Source: secondary_id

PC3

Identifier Type: -

Identifier Source: org_study_id