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Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
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Purpose
The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine in the most severe form of ulcerative colitis.
The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.
| Condition | Intervention | Phase |
|---|---|---|
| Ulcerative Colitis | Drug: retarded release phosphatidylcholine | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa |
- Absolute change in clinical activity index (Rachmilewitz).
- Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).
- Histology and life quality are reported descriptively.
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | March 2006 |
Design: prospective, randomized, double-blind, dose-finding study with retarded phosphatidylcholine.
Population: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to historic groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at least 7 or more. No systemic steroids or immunosuppressants since 4 weeks.
Exclusion criteria: Pregnancy & fulminant course
Eligibility| Ages Eligible for Study: | 16 Years to 90 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- chronic active ulcerative pancolitis
- course more than 4 months
- clinical index rachmilewitz 7 or more
- endoskopic index 7 or more
Exclusion Criteria:
- steroids in the last 4 weeks
- immunosuppressants in the last 4 weeks
- use of topical klymsa
- pregnancy
- fulminant course
- infectious colitis
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00259558
| Germany | |
| Medical Hospital Unversity Heidelberg | |
| Heidelberg, Germany, 69120 | |
| Principal Investigator: | Wolfgang Stremmel, Professor | University Heidelberg |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00259558 History of Changes |
| Other Study ID Numbers: |
PC3 EC - L069/2003 BFARM - 402 2919 |
| Study First Received: | November 25, 2005 |
| Last Updated: | February 7, 2007 |
Keywords provided by Heidelberg University:
|
Ulcerative Colitis Dose Finding Phosphatidylcholine |
Additional relevant MeSH terms:
|
Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |
ClinicalTrials.gov processed this record on June 23, 2017