Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis

Last updated: February 7, 2017
Sponsor: Dr. Falk Pharma GmbH
Overall Status: Terminated

Phase

3

Condition

Inflammatory Bowel Disease

Ulcerative Colitis

Ulcers

Treatment

N/A

Clinical Study ID

NCT02142725
PCG-2/UCA
2012-003702-27
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Established diagnosis of ulcerative colitis

  • Active ulcerative colitis disease extent ≥ 15 cm

  • Active disease despite treatment with mesalamine

Exclusion

Exclusion Criteria:

  • Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,microscopic colitis, diverticular disease associated colitis,

  • Toxic megacolon or fulminant colitis

  • Colon resection

  • Evidence of infectious colitis

  • Celiac disease

  • Bleeding hemorrhoids

  • History or presence of ischemic heart disease, myocardial infarction, peripheralarterial disease, ischemic stroke, or transient ischemic attack

  • Any severe concomitant renal, endocrine, or psychiatric disorder

  • Any relevant known systemic disease

  • History of cancer in the last five years

  • Abnormal hepatic function or liver cirrhosis

  • Abnormal HbA1c at screening visit

  • Patients with known hypersensitivity to soy

  • Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)

  • Treatment with steroids/methotrexate/Tumor necrosisfactor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins

  • Treatment with other investigational drug

  • Existing or intended pregnancy or breast-feeding

Study Design

Total Participants: 468
Study Start date:
July 21, 2014
Estimated Completion Date:
December 16, 2016

Connect with a study center

  • Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine

    Frankfurt a.M., 60431
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.