Dose Finding Study for Retarded Phosphatidylcholine in Pa... | NCT00259558

Studies
Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

NCT00259558

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Feb 12, 2007Estimated

Enrollment

Phase

Phase 2

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

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Nov 25, 2005

First Submission Date that Met QC Criteria

Nov 25, 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

Feb 7, 2007

Last Update Posted Date

Feb 12, 2007Estimated

Name	Class
Prof. Wolfgang Stremmel	UNKNOWN
Dietmar Hopp Stiftung	OTHER

Description Module

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

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
retarded release phosphatidylcholine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute change in clinical activity index (Rachmilewitz).

Secondary Outcomes

Measure	Description	Time Frame
Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
Histology and life quality are reported descriptively.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 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	University Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Hospital Unversity 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.
20048683	Derived	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.

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

ID	Type	Description	Link
EC - L069/2003
BFARM - 402 2919