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 个研究点目标入组 762 人开始时间: 2014年3月7日最近更新: 2017年10月2日

适应症

试验速览

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•- 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 Patients not in remission of UC at week 12, or patients withdrawn = 8 weeks after randomization due to lack of efficacy and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

•- 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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