MedTrace Logo

Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

NCT00463619 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2011-08-16

No results posted yet for this study

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:

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

Conditions

Interventions

DRUG

Retarded release phosphatidylcholine

2g phosphatidylcholine, given QTD

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Max Karner, MD · University Heidelberg - Gastroenterology

  • Verena Schmieg, Cand. med. · Heidelberg University

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-04-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00463619 on ClinicalTrials.gov