T-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis
- Conditions
- Acute Ulcerative Colitis (UC)MedDRA version: 16.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-003702-27-LV
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 762
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 Patients not in remission of UC at week 12, or patients withdrawn = 8 weeks after randomization due to lack of efficacy and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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary: <br>• To prove the superiority of a 12-week add-on treatment with 3.2 g/day gastro-resistant phosphatidylcholine granules (LT-02) in at least one of two different dosing regimens versus LT-02 placebo for the induction of remission in patients with ulcerative colitis (UC) refractory to standard <br>treatment with mesalamine.;Secondary Objective: Secondary: <br>• To study safety and tolerability in the form of adverse events (AEs) and laboratory parameters, <br>• To compare two different dosing regimens of LT-02, <br>• To assess patients’ quality of life.;Primary end point(s): Percentage of patients in remission;Timepoint(s) of evaluation of this end point: after week 12 (LOCF) of double-blind treatment phase
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Double-blind (12-week) and optional open-label (12-week) phase: <br>• Percentage of patients with clinical improvement, <br>• Times to first resolution of clinical symptoms, <br>• Number of stools per week, <br>• Number of bloody stools per week, <br>• Number of days with urgency per week, <br>• Percentage of patients with mucosal healing, <br>• Percentage of patients with histologic remission, <br>• Patients quality of life,<br><br>Open-label phase (only): <br>• Percentage of patients in remission at end of OL phase.;Timepoint(s) of evaluation of this end point: after week 12 (LOCF) of double-blind and/or open-label treatment phase