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Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

NCT ID: NCT00259545

Last Updated: 2008-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-02-28

Brief Summary

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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

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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

Conditions

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Ulcerative Colitis Phosphatidylcholine

Keywords

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retarded phosphatidylcholine chronic active steroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Retarded Release Phosphatidylcholine (rPC)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Professor Wolfgang Stremmel

UNKNOWN

Sponsor Role collaborator

Dietmar Hopp Stiftung

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Wolfgang Stremmel, Professor

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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University Heidelberg - Medical Department 4 - Gastroenterology

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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, Ehehalt R, Autschbach F, Karner M. Phosphatidylcholine for steroid-refractory chronic ulcerative colitis: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):603-10. doi: 10.7326/0003-4819-147-9-200711060-00004.

Reference Type DERIVED
PMID: 17975182 (View on PubMed)

Other Identifiers

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EC - L71/2003

Identifier Type: -

Identifier Source: secondary_id

BFARM - 402 29 17

Identifier Type: -

Identifier Source: secondary_id

PC2

Identifier Type: -

Identifier Source: org_study_id