NCT03569007终止3 期
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 307
- 试验地点
- 1
- 主要终点
- Proportion of subjects who are binary responders
研究概览
简要总结
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
详细描述
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.
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, Investigator, Outcomes Assessor)
盲法说明
Double-blind
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
- •Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months
- •On a gluten-free diet for at least 6 months
- •Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
- •Willing to maintain current gluten-free diet throughout participation in the study
排除标准
- •Refractory celiac disease or severe complications of celiac disease
- •Chronic active GI disease other than celiac disease
研究组 & 干预措施
Larazotide 0.25 mg
Active Comparator
Larazotide 0.25 mg capsules TID
干预措施: Larazotide (Drug)
Larazotide 0.50 mg
Active Comparator
Larazotide 0.50 mg capsules TID
干预措施: Larazotide (Drug)
Placebo
Placebo Comparator
Matching placebo capsules TID
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Proportion of subjects who are binary responders
时间窗: 12 weeks
Reduction in CeD PRO Abdominal Domain scores
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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