Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis
Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis
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.
- Retarded release phosphatidylcholine in chronic-active ulcerative colitis.
- Retarded release phosphatidylcholine in steroid dependent ulcerative colitis.
- Dose finding study for retarded release phosphatidylcholine
Definition of remission:
- SCCAI <2,5
- Likert scale: grade 1 or 2
- subjective impression of remission: yes/no
- no blood in stool
Definition of relapse:
- subjective impression: yes/no
- SCCAI ≥ 5
- blood in stool
Definition of low clinical activity: SCCAI < 5
sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC.
- maintenance of continuous remission
- improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D) c.Likert Score
- relapse rate: a. time to first relapse b. clinical activity during relapses c. number of relapses in relation to length of treatment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463619
|University Heidelberg - Dep. Gastroenterology|
|Heidelberg, Germany, 69120|
|Study Chair:||Max Karner, MD||University Heidelberg - Gastroenterology|
|Principal Investigator:||Verena Schmieg, Cand. med.||Heidelberg University|