Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Heidelberg - Dep. Gastroenterology

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retarded release phosphatidylcholine

Drug

2g phosphatidylcholine, given QTD

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Important dates

Study start: 2000
Primary completion: 2010
Study completion: 2010
First posted: Apr 20, 2007
Registry last updated: Aug 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed