Ulcerative Colitis
Conditions
Brief summary
The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)
Interventions
DRUGLT-02
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
DRUGPlacebo
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
DRUGMesalamine
LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * Signed informed consent * Men or women, 18 to 70 years of age * Historically confirmed diagnosis of UC by endoscopy and histology * Patients being in clinical and endoscopical remission at baseline * Negative pregnancy test in females of childbearing potential at baseline visit Major
Exclusion criteria
* Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis * Toxic megacolon or fulminant colitis * Colon resection * Malabsorption syndromes * Celiac disease * Bleeding hemorrhoids * 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 * Any severe concomitant renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results * Any relevant known systemic disease (e.g., AIDS, active tuberculosis) * Severe co-morbidity substantially reducing life expectancy * History of cancer in the last five years * Abnormal hepatic function at screening visit, liver cirrhosis * Abnormal renal function at screening visit * Patients with known hypersensitivity to soy * Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine) * 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 mesalamine or corticosteroid formulations within last 2 weeks prior to randomization * Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02 * Existing or intended pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who are relapse-free and are not a treatment failure | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in the total mDAI | 48 weeks |
Countries
Germany
Outcome results
None listed