Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT00463619|
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : August 16, 2011
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
|Condition or disease||Intervention/treatment|
|Ulcerative Colitis||Drug: Retarded release phosphatidylcholine|
|Study Type :||Observational|
|Actual Enrollment :||132 participants|
|Study Start Date :||April 2000|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
- Drug: Retarded release phosphatidylcholine
2g phosphatidylcholine, given QTD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463619
|University Heidelberg - Dep. Gastroenterology|
|Heidelberg, Germany, 69120|
|Study Chair:||Max Karner, MD||University Heidelberg - Gastroenterology|
|Principal Investigator:||Verena Schmieg, Cand. med.||Heidelberg University|