Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

August 15, 2011 updated by: Heidelberg University

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:

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

Definition of relapse:

  1. subjective impression: yes/no
  2. SCCAI ≥ 5
  3. 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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Heidelberg - Dep. Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from previous studies with retarded release phosphatidylcholine

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Study Chair: Max Karner, MD, University Heidelberg - Gastroenterology
  • Principal Investigator: Verena Schmieg, Cand. med., Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 18, 2007

First Posted (ESTIMATE)

April 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVT123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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