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 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC

Dr. Falk Pharma GmbH0 sites762 target enrollmentStarted: March 19, 2014Last updated: August 21, 2017

Conditions

Trial Snapshot

No summary available.

•Principle - Men or women, 18 to 70 years of age, - Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings, - Active UC with disease extent = 15 cm (proctitis only patients to be excluded), confirmed by endoscopy and histology, - Mesalamine (5-ASA) refractory disease, - Elevated stool calprotectin at screening. Inclusion criteria for open-label sub-study: The following inclusion criterion will apply only to the open label sub-study: 1. Patients not in remission of UC at week 12, or patients withdrawn = 8 weeks after randomization due to lack of efficacy and showing no clinical improvement.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 720
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 42

•Principle - Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis, - Colon resection, - Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening), - 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, - 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 corticosteroid formulation within last 2 weeks prior to randomization, - Concomitant treatment with coumarins (e.g., phenprocoumon), - Existing or intended pregnancy or breast-feeding.

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