A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Remission evaluated by DAI scores at 14 and 28 days
研究概览
简要总结
The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.
详细描述
Ulcerative colitis is a relapsing disease of unknown cause characterized by bloody diarrhea. Therapy usually involves 5-aminosalicylates, corticosteroids and immunosuppressants. However, steroid resistance and dependency can become problematic. Immunosuppressive drugs, such as azathioprine, are beneficial but may have serious side effects. Therefore, new therapeutic approach is needed.
Prostaglandin E2 is one of the prostanoids, which is involved with innate immunity. PGE2 induces oral tolerance to specific antigen in the small intestine and downregulates the production and release of proinflammatory cytokines by macrophages and neutrophils. Accordingly, PGE2 is considered to be the mediator of mucosal protection.
Recently, it was elucidated that disruption of EP4 gene, which is one of PGE receptors, caused severe colitis in mice. Moreover, EP4-selective agonist (AE1-734) was also revealed to ameliorate severe dextran sodium sulfate-induced colitis in mice. We therefore examined the effects of 2 weeks intravenous EP4-selective agonist therapy for patients with mild to moderate ulcerative colitis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ulcerative colitis
- •Mild to moderate ulcerative colitis refractory to 5-aminosalicylates therapy.
- •20 years and above
- •Must obtain written informed consent
排除标准
- •Corticosteroids therapy within two weeks before enrollment
- •Immunosuppressive therapy within three months before enrollment
- •Leukocytapheresis therapy within one month before enrollment
- •Blood transfusion within two weeks before enrollment
- •Impaired renal function
- •Impaired hepatic function
- •Uncontrolled hypertension/hypotension
- •Uncontrolled arrhythmia
- •Impaired cardiac function
- •Uncontrolled diabetes
- •Interstitial pneumonia
- •History of colon resection
- •Infectious diseases needing medical treatments
- •Drug allergy
结局指标
主要结局
Remission evaluated by DAI scores at 14 and 28 days
次要结局
- Improvement by DAI scores; Change in DAI scores; CAI scores at 3, 7, 14 and 28 days; Colonoscopic and histopathological scores at 14 and 28 days; Clinical severity and symptom scores at 7, 14 and 28 days; Cytokines at 7, 14 and 28 days; Adverse effects.