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Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00463619
First received: April 18, 2007
Last updated: August 15, 2011
Last verified: April 2010
History of Changes
  Purpose

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

Condition Intervention
Ulcerative Colitis
 Drug: Retarded release phosphatidylcholine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Drug Information available for: Lecithin
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Enrollment: 132
Study Start Date: April 2000
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Retarded release phosphatidylcholine
    2g phosphatidylcholine, given QTD
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from previous studies with retarded release phosphatidylcholine

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463619

Locations
Germany
University Heidelberg - Dep. Gastroenterology
Heidelberg, Germany, 69120
Sponsors and Collaborators
University of Heidelberg
Investigators
Study Chair: Max Karner, MD University Heidelberg - Gastroenterology
Principal Investigator: Verena Schmieg, Cand. med. University of Heidelberg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463619     History of Changes
Other Study ID Numbers: AVT123
Study First Received: April 18, 2007
Last Updated: August 15, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013