NCT00463619

Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Retarded release phosphatidylcholine	2g phosphatidylcholine, given QTD

Timeline

• Start date: 2000-04-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-04-20
• Last updated: 2011-08-16

Locations

1 site across 1 country: Germany