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Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463619
First Posted: April 20, 2007
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  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:


Further study details as provided by Heidelberg University:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00463619     History of Changes
Other Study ID Numbers: AVT123
First Submitted: April 18, 2007
First Posted: April 20, 2007
Last Update Posted: August 16, 2011
Last Verified: April 2010

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