T-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Inclusion criteria for DB maintenance phase:
1.Signed informed consent,
2.Men or women, 18 to 70 years of age,
3.Historically confirmed diagnosis of UC by endoscopy and histology,
4.Patients being in remission at baseline,
5.Negative pregnancy test in females of childbearing potential at baseline visit,
6.Women of child-bearing potential have to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly.
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 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Exclusion criteria for DB maintenance phase:
1.Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
2.Toxic megacolon or fulminant colitis,
3.Colon resection,
4.Malabsorption syndromes,
5.Celiac disease,
6.Bleeding hemorrhoids,
7.Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
8.History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
9.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,
10.Any relevant known systemic disease (e.g., AIDS, active tuberculosis),
11.Severe co-morbidity substantially reducing life expectancy,
12.History of cancer in the last five years,
13.Abnormal hepatic function at the screening visit), liver cirrhosis,
14.Abnormal renal function at the screening visit,
15.Either HbA1c =6.5% (=48 mmol/mol) at baseline visit, OR HbA1c >5.6% (38 mmol/mol) AND fasting blood glucose =100 mg/dl (=5.6 mmol/l) at baseline visit,
16.Patients with known hypersensitivity to soy,
17.Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine),
18.Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization,
19.Treatment with methotrexate within last 6 weeks prior to randomization,
20.Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization,
21.Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization,
22.Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02,
23.Concomitant treatment with coumarins (e.g., phenprocoumon),
24.Unwillingness to undergo endoscopy with biopsy sampling at end of treatment (EOT)/withdrawal visit of this study,
25.Clinical suspicion of addiction to alcohol or drugs,
26.Existing or intended pregnancy or breast-feeding,
27.Subjects deemed by the investigator to be unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study,
28.Participation in another clinical trial within the last 30 days prior to baseline visit (except for the Phase III study PCG-2/UCA), simultaneous participation in another clinical trial, or previous participation in this trial and having received IMP.

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 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)<br>;Secondary Objective: Secondary:<br>To study safety and tolerability in the form of adverse events (AEs) and laboratory parameters,<br>To assess patients’ quality of life.<br>;Primary end point(s): Percentage of patients who are relapse-free and are not a treatment failure after 48 weeks of treatment. ;Timepoint(s) of evaluation of this end point: After week 48 (LOCF) of double-blind treatment phase

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Mean change from baseline in the total mDAI at V6/EOT.<br>•Time to relapse or discontinuation,<br>•Time to relapse.;Timepoint(s) of evaluation of this end point: After week 48 (LOCF) of double-blind treatment phase

Updated 12/12/2016

T-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Recruitment & Eligibility

Study & Design

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T-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis