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

• Status: Terminated
• Trial end date: 2016-12-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH

Criteria

Inclusion Criteria:

• Established diagnosis of ulcerative colitis

• Active ulcerative colitis disease extent ≥ 15 cm

• Active disease despite treatment with mesalamine

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, peripheral arterial 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 necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins

• Treatment with other investigational drug

• Existing or intended pregnancy or breast-feeding