NCT00572585已完成2 期
A Randomized, Double Blind, Placebo Controlled, Parallel Group Design Study to Explore the Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of induction of remission after 28 days of treatment (using the Partial Mayo Score and the Modified Baron Score), also an Endoscopic biopsy will be taken
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years males and females
- •Female subjects of childbearing potential must be using two methods of contraception
- •Active, moderate to severe disease
- •Poor response to or no toleration of conventional therapy (e.g. steroids, mesalamine)
- •Good communication with the investigator, understanding and compliance with the requirements of the study and written informed consent
排除标准
- •Allergy to the drug
- •Very low or high body weight
- •Ongoing treatment with specific other medication (e.g. antibiotics)
- •Diagnosis of primary sclerosing cholangitis
- •Renal impairment
- •Toxic megacolon
- •Presence or history of specific other diseases, cancer, cardiac abnormalities, abnormal laboratory findings
- •History of alcohol or drug abuse
- •Pregnant or breastfeeding women
- •Positive HIV, Hepatitis B or Hepatitis C test result
- •Other protocol-defined inclusion/exclusion criteria do apply
研究组 & 干预措施
AEB071
Experimental
干预措施: AEB071 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of induction of remission after 28 days of treatment (using the Partial Mayo Score and the Modified Baron Score), also an Endoscopic biopsy will be taken
时间窗: Partial Mayo Score throughout entire study, biopsy at end of dosing period
次要结局
- Measurement of drug concentrations in blood(During the dosing period only)
- Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)(Throughout entire study)
- Relationship between drug concentration in blood and disease activity(Dosing period only)
研究者
研究点 (1)
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