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
- Conditions
- Colitis UlcerosaCrohn's disease10017969
- Registration Number
- NL-OMON42292
- Lead Sponsor
- Dr. Falk Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
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 Patients not in remission of UC at week 12, or patients withdrawn 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of patients in deep remission (defined as mDAI Score <= 1 with a<br /><br>score of *0* points for rectal bleeding and stool frequency, and >= 1 point<br /><br>reduction from baseline in the mucosal appearance score) at week 12<br /><br>(LOCF).</p><br>
- Secondary Outcome Measures
Name Time Method