NCT02745678已完成1 期
Localized Therapeutics for the Treatment of Gastrointestinal Disorders II
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)
研究概览
简要总结
The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign written informed consent.
- •Male or non-pregnant and non-lactating females at least 8 years of age.
- •Confirmed diagnosis of active, mild to moderate ulcerative proctitis or proctosigmoiditis extending no further than 40cm from the anal verge. Typically, baseline Mayo Disease Activity Index (MMDAI) score between 5 and 10 (indicating mild to moderate disease).
排除标准
- •Known infection with Clostridium difficile (C. difficile) and/or other enteric pathogens
- •5-aminosalicylic acid (5-ASA) intolerance
- •Current or recent (3 weeks) oral or rectal steroids
- •History of thiopurine or Anti-tumor necrosis factor (Anti-TNF) alpha treatment for colitis
- •Abnormal creatinine
- •Previous small bowel or colonic resection,
- •Anal sphincter incompetence,
- •Current smokers.
- •History or current diagnosis of Crohn's disease or indeterminate colitis.
- •History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
- •Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
- •Hemoglobin levels < 7.5 g/dL.
- •History of sclerosing cholangitis, cirrhosis, or hepatic impairment
- •Pregnant or at risk of pregnancy.
- •Some medications to treat UC are prohibited during participation in the study, including laxatives and anti-diarrhea medications; oral 5-ASA agents and daily fiber supplements are allowed.
研究组 & 干预措施
Thermosensitive gel formulation
Experimental
Thermosensitive gel rectal formulation.
干预措施: Thermosensitive gel rectal formulation (Drug)
结局指标
主要结局
Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)
时间窗: Between 4-6 weeks post-administration
Using Modified Mayo Score
次要结局
未报告次要终点
研究者
Sidhartha R Sinha
MD
Stanford University
研究点 (1)
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