A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 305
- 主要终点
- Proportion of subjects who were relapse free after 6 months of treatment.
研究概览
简要总结
The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.
详细描述
This is a phase 3, multicenter, double-blind, randomized, placebo controlled study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared with placebo in approximately 300 subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 of 2 treatments: 1.5g eMG QD (four capsules total) or matching placebo capsules QD for 6 months.
The study consists of a Screening phase (completed within 7 days prior to randomization), a Treatment phase (6 months), and a Follow-up visit (2 weeks after end-of-study [EOS] visit). The Treatment phase consists of 4 scheduled study visits: Visit 1 (Baseline)/Randomization (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4/EOS (Month 6).
Primary objective:
To compare the maintenance of remission from mild to moderate ulcerative colitis (UC) as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) at 1.5 g QD, as compared with placebo.
Secondary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month.
- •Greater than 18 years of age.
排除标准
- •Allergy/intolerance to aspirin, mesalamine or other salicylates.
- •Prior bowel surgery other than appendectomy.
- •Pregnancy, at risk of pregnancy or lactating.
- •HIV or hepatitis B or C.
研究组 & 干预措施
2
Placebo
干预措施: Placebo (Drug)
1
Granulated mesalamine
干预措施: Granulated mesalamine (Drug)
结局指标
主要结局
Proportion of subjects who were relapse free after 6 months of treatment.
时间窗: 6 months
次要结局
未报告次要终点