NCT02280629已完成3 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of patients who are relapse-free and are not a treatment failure
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
LT-02
Experimental
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
干预措施: LT-02 (Drug)
Placebo
Placebo Comparator
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
干预措施: Placebo (Drug)
Mesalamine
Active Comparator
LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily
干预措施: Mesalamine (Drug)
结局指标
主要结局
Percentage of patients who are relapse-free and are not a treatment failure
时间窗: 48 weeks
次要结局
- Mean change from baseline in the total mDAI(48 weeks)
研究者
研究点 (1)
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