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NCT00463619 Clinical Trial

Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00463619
Other study ID # AVT123
Secondary ID
Status Completed
Phase N/A
First received April 18, 2007
Last updated August 15, 2011
Start date April 2000
Est. completion date April 2010

Study information
Verified date April 2010
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Retarded release phosphatidylcholine
2g phosphatidylcholine, given QTD

Locations
Country Name City State
Germany University Heidelberg - Dep. Gastroenterology Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

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