EUCTR2013-001205-84-LV进行中（未招募）1 期
Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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