Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

Heidelberg University

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Drug: Retarded release phosphatidylcholine

Study type: Observational

Funder types: Other

Identifiers

NCT00463619

AVT123

Details and patient eligibility

About

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

Enrollment: 132 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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