Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis
- Registration Number
- NCT02142725
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 468
Inclusion Criteria
- Established diagnosis of ulcerative colitis
- Active ulcerative colitis disease extent ≥ 15 cm
- Active disease despite treatment with mesalamine
Exclusion Criteria
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis
- Colon resection
- Evidence of infectious colitis
- Celiac disease
- Bleeding hemorrhoids
- 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
- Any relevant known systemic disease
- History of cancer in the last five years
- Abnormal hepatic function or liver cirrhosis
- Abnormal HbA1c at screening visit
- Patients with known hypersensitivity to soy
- Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
- Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
- Treatment with other investigational drug
- Existing or intended pregnancy or breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo LT-02 Placebo B: LT-02 LT-02 LT-02 1.6g twice daily LT-02 LT-02 LT-02 0.8g four times daily
- Primary Outcome Measures
Name Time Method Rate of clinical remission 12 weeks
- Secondary Outcome Measures
Name Time Method Number of days with urgency per week 12 weeks Number of stools per week 12 weeks Physician's global assessment at final visit 12 weeks Rate of patients with clinical improvement 12 weeks Time to first resolution of symptoms 12 weeks Rate of mucosal healing 12 weeks Rate of histologic remission 12 weeks Quality of life 12 weeks
Trial Locations
- Locations (1)
Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
🇩🇪Frankfurt a.M., Germany