NCT00463619

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:
  • SCCAI \<2,5
  • Likert scale: grade 1 or 2
  • subjective impression of remission: yes/no
  • no blood in stool
  • subjective impression: yes/no
  • SCCAI ≥ 5
  • blood in stool
  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 16, 2011

Status Verified

April 1, 2010

Enrollment Period

10 years

First QC Date

April 18, 2007

Last Update Submit

August 15, 2011

Conditions

Ulcerative Colitis

Interventions

Retarded release phosphatidylcholineDRUG

2g phosphatidylcholine, given QTD

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from previous studies with retarded release phosphatidylcholine

You may qualify if:

  • Patients from previous studies with retarded release phosphatidylcholine

You may not qualify if:

  • patients with less then 6 weeks follow-up after end of initial study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Heidelberg - Dep. Gastroenterology

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Max Karner, MD

    University Heidelberg - Gastroenterology

    STUDY CHAIR

  • Verena Schmieg, Cand. med.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

April 1, 2000

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 16, 2011

Record last verified: 2010-04

Locations

DE(1)