Retarded Phosphatidylcholine Versus Mesalazin in Remissio... | NCT00259571

Studies
Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

NCT00259571

Sponsor

Heidelberg University

Status

Withdrawn

Last Update Posted

Dec 13, 2013Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Ulcerative Colitis

Interventions

retarded release phosphatidylcholine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Missing financial sponsorship

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Mar 2010

First Submitted Date

Nov 28, 2005

First Submission Date that Met QC Criteria

Nov 28, 2005

First Posted Date

Nov 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2013

Last Update Posted Date

Dec 13, 2013Estimated

Name	Class
Dietmar Hopp Stiftung	OTHER

Description Module

Brief Summary

The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis.

The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
retarded release phosphatidylcholine	Drug	2g daily, given orally QTD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of relapses
relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days

Secondary Outcomes

Measure	Description	Time Frame
time to the first relapse
amount of relapses per year
endoscopic index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of ulcerative colitis in remission (CAI 3 or less)
signed letter of content
no steroids or immunosupressants in the last 6 weeks
at least 5 relapses in the last 3 years
last relapse was 8 months ago or less
complete colonoscopy at entry

Exclusion Criteria:

pregnancy or breast feeding
steroids or immunosuppressants
acute episode of UC
condition after complete or partial colektomy
known intolerance to mesalazin
severe medical disease other than colitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolfgang Stremmel, Professor	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Hospital - University of Heidelberg		Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15951544	Background	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.

ID	Term
D003093	Colitis, Ulcerative
D012008	Recurrence

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Type	Description	Link
EC - L389/2003
BFARM - 402 2918