NCT02037776已完成4 期
Double-blind Trial With Rikkunshito Versus Placebo on Efficacy and Safety in Patients With Functional Dyspepsia: Multi-center Study (DREAM Study)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •-Patients diagnosed with FD according to the ROME III criteria i) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to obtaining informed consent ii) Have not received upper endoscopy within the last 6 months prior to enrollment and do not have evidence of structural/organic disease iii) Must have one or more of the following symptoms:
- •Bothersome postprandial fullness
- •Early satiation
- •Epigastric pain
- •Epigastric burning
- •At least one of the FD-related symptoms on the Global Overall Symptom (GOS) scale (bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning) is ≥4, whereas heartburn is ≤
- •Total score of depression-related symptoms on Hospital Anxiety and Depression Score (HAD) is ≤
- •Type of visit: Outpatient
- •Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.
排除标准
- •Confirmed ulcer (excluding scars) or malignant tumor in the upper GI
- •Suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis
- •History of upper GI resection
- •Serious complications (liver, kidney, heart, or blood disease or metabolic disease)
- •Less than a year since testing positive for H. pylori or have undergone a successful eradication therapy
- •Use of prohibited medications
- •Neuropsychiatric disorders
- •Use of or planned use of any investigational drugs
- •Unable to take drugs orally
- •History of allergic reactions to Kampo medicines
- •Pregnant or lactating women or those who are planning to conceive during the study period
- •Deemed ineligible by principal investigator or sub-investigator
研究组 & 干预措施
Rikkunshito Placebo
Placebo Comparator
干预措施: Rikkunshito placebo (Drug)
Rikkunshito
Active Comparator
干预措施: Rikkunshito (Drug)
结局指标
主要结局
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
时间窗: 8 weeks
Patient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories: 1. Significantly improved 2. Improved 3. Slightly improved 4. No change 5. Slightly worse 6. Worse 7. Much worse The numbers of patients at the final evaluation (i.e, the latest evaluable time point of the all patients including discontinued patients) are shown by category.
次要结局
- Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)(Baseline and Week 8)
- Change From Baseline in Global Overall Symptom (GOS)(Baseline and Week 8)
- Change From Baseline in Hospital Anxiety and Depression Scale (HAD)(Baseline and week 8)
- Change From Baseline in Short-form Health Survey-8 (SF-8)(Baseline and week 8)
- Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)(Baseline and Week 8)
研究者
Kazunari Tominaga
M.D., Ph.D.
Osaka Medical College
研究点 (1)
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