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

Ulcerative Colitis Clinical Trial

— PROTECT-1  

Official title:

Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02142725
• Other study ID #: PCG-2/UCA
• Secondary ID: 2012-003702-27
• Status: Terminated
• Phase: Phase 3
• First received: May 15, 2014
• Last updated: February 7, 2017
• Start date: July 21, 2014
• Est. completion date: December 16, 2016

Study information

• Verified date: February 2017
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 468
• Est. completion date: December 16, 2016
• Est. primary completion date: November 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• LT-02
four times per day
• LT-02
two times per day
• Placebo
four times per day

Locations

Country	Name	City	State
Germany	Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine	Frankfurt a.M.

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical remission		12 weeks
Secondary	Rate of patients with clinical improvement		12 weeks
Secondary	Time to first resolution of symptoms		12 weeks
Secondary	Number of stools per week		12 weeks
Secondary	Number of days with urgency per week		12 weeks
Secondary	Rate of mucosal healing		12 weeks
Secondary	Rate of histologic remission		12 weeks
Secondary	Physician's global assessment at final visit		12 weeks
Secondary	Quality of life		12 weeks