Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)

Ulcerative Colitis Clinical Trial

— PROTECT-2  

Official title:

Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280629
• Other study ID #: PCG-4/UCR
• Secondary ID: 2013-001205-84
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2014
• Est. completion date: October 5, 2018

Study information

• Verified date: January 2020
• 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 prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Major Inclusion Criteria:

• Signed informed consent

• Men or women, 18 to 70 years of age

• Historically confirmed diagnosis of UC by endoscopy and histology

• Patients being in clinical and endoscopical remission at baseline

• Negative pregnancy test in females of childbearing potential at baseline visit

Major Exclusion Criteria:

• Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis

• Toxic megacolon or fulminant colitis

• Colon resection

• Malabsorption syndromes

• Celiac disease

• Bleeding hemorrhoids

• Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding

• 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, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results

• Any relevant known systemic disease (e.g., AIDS, active tuberculosis)

• Severe co-morbidity substantially reducing life expectancy

• History of cancer in the last five years

• Abnormal hepatic function at screening visit, liver cirrhosis

• Abnormal renal function at screening visit

• Patients with known hypersensitivity to soy

• Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine)

• Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization

• Treatment with methotrexate within last 6 weeks prior to randomization

• Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization

• Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization

• Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02

• Existing or intended pregnancy or breast-feeding

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• LT-02
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
• Placebo
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
• Mesalamine
LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily

Locations

Country	Name	City	State
Germany	Agaplesion Markus-Krankenhaus	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	Percentage of patients who are relapse-free and are not a treatment failure		48 weeks
Secondary	Mean change from baseline in the total mDAI		48 weeks