Multi-center, Randomized, Active-Controlled, Double-Blind, Non-Inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia (MARS Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 主要终点
- Change of symptom score of functional dyspepsia
研究概览
简要总结
This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.
详细描述
Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >19 years
- •Diagnosis of functional dyspepsia meeting Rome III criteria
- •At least three moderate or severe symptoms included in the Symptom Score
- •No structural lesions of upper gastrointestinal tract
排除标准
- •History of dyspepsia unrelated to functional dyspepsia or diseases
- •History of gastrointestinal surgery
- •History of malignancy in the previous 5 years
- •Psychiatric disorders including major depressive disorder and anxiety
- •Liver cirrhosis or abnormal liver laboratory findings
- •Advanced chronic kidney disease
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Pregnancy and lactation
- •Recent history of taking medication affecting the gastrointestinal system
研究组 & 干预措施
UI05MSP015CT
UI05MSP015CT and Placebo of Gasmotin
干预措施: UI05MSP015CT (Drug)
Gasmotin
Placebo of UI05MSP015CT and Gasmotin
干预措施: Gasmotin (Drug)
结局指标
主要结局
Change of symptom score of functional dyspepsia
时间窗: 4weeks
Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.
次要结局
- Change of symptom score of functional dyspepsia(2weeks)
- NDI-K questionnaire(4weeks)
- General symptom improvement(2weeks, 4weeks)