Follow-up Study With Retarded Release Phosphatidylcholine... | NCT00463619

Studies
Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

NCT00463619

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Aug 16, 2011Estimated

Enrollment

132Actual

Phase

Not provided

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

Apr 2010

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 2000

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Apr 18, 2007

First Submission Date that Met QC Criteria

Apr 18, 2007

First Posted Date

Apr 20, 2007Estimated

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

Aug 15, 2011

Last Update Posted Date

Aug 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis

Objectives:

The objective of the study is to evaluate the follow up of patients treated with retarded release phosphatidylcholine in three controlled, randomized studies.

Main question is to investigate whether treatment with phosphatidylcholine could spare patients the intake of steroids and immunosuppressants without clinical deterioration.

Study population:

Retarded release phosphatidylcholine in chronic-active ulcerative colitis.
Retarded release phosphatidylcholine in steroid dependent ulcerative colitis.
Dose finding study for retarded release phosphatidylcholine

Outcome parameters:

Definition of remission:

SCCAI <2,5
Likert scale: grade 1 or 2
subjective impression of remission: yes/no
no blood in stool

Definition of relapse:

subjective impression: yes/no
SCCAI ≥ 5
blood in stool

Definition of low clinical activity: SCCAI < 5

Primary endpoint:

sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC.

Secondary endpoints

maintenance of continuous remission
improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D) c.Likert Score
relapse rate: a. time to first relapse b. clinical activity during relapses c. number of relapses in relation to length of treatment

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients from previous studies with retarded release phosphatidylcholine

Exclusion Criteria:

patients with less then 6 weeks follow-up after end of initial study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients from previous studies with retarded release phosphatidylcholine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Max Karner, MD	University Heidelberg - Gastroenterology	Study Chair
Verena Schmieg, Cand. med.	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Heidelberg - Dep. Gastroenterology		Heidelberg		69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided