Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463619
Status:
COMPLETED
Last Update Posted:
2011-08-16
First Post:
2007-04-18
Brief Title:
Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 SCCAI 25
2 Likert scale grade 1 or 2
3 subjective impression of remission yesno
4 no blood in stool
Definition of relapse
1 subjective impression yesno
2 SCCAI 5
3 blood in stool
Definition of low clinical activity SCCAI 5
Primary endpoint
sparing effect of steroids andor immunosuppressants by rPC in chronic active UC
Secondary endpoints
1 maintenance of continuous remission
2 improvement of disease activity a clinical activity SCCAI blife quality SIBDQ-D cLikert Score
3 relapse rate a time to first relapse b clinical activity during relapses c number of relapses in relation to length of treatment
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 25
2 Likert scale grade 1 or 2
3 subjective impression of remission yesno
4 no blood in stool
Definition of relapse
1 subjective impression yesno
2 SCCAI 5
3 blood in stool
Definition of low clinical activity SCCAI 5
Primary endpoint
sparing effect of steroids andor immunosuppressants by rPC in chronic active UC
Secondary endpoints
1 maintenance of continuous remission
2 improvement of disease activity a clinical activity SCCAI blife quality SIBDQ-D cLikert Score
3 relapse rate a time to first relapse b clinical activity during relapses c number of relapses in relation to length of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None