Status:
COMPLETED
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 wit...
Eligibility Criteria
Inclusion
- Major
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02280629
Start Date
October 1 2014
End Date
October 5 2018
Last Update
January 27 2020
Active Locations (1)
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1
Agaplesion Markus-Krankenhaus
Frankfurt a.M., Germany, 60431