Clinical trial NCT02280629: Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who are relapse-free and are not a treatment failure
timeFrame: 48 weeks
Secondary outcomes:
measure: Mean change from baseline in the total mDAI
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Frankfurt a.M.
country: Germany
facility: Agaplesion Markus-Krankenhaus
Study officials:
affiliation: Agaplesion Markus Krankenhaus
name: Axel Dignass, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: