NCT01240096已完成4 期
Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Difference in dyspepsia symptom scores week 8 versus week 0
研究概览
简要总结
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily
详细描述
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg or placebo, followed by 8 weeks of open-label mirtazapine
Two weeks run-in, 8 weeks randomized, 8 weeks open label
Assessments include
- dyspepsia questionnaire
- Nepean dyspepsia index
- Daily diary
- Vital signs
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional dyspepsia according to Rome II criteria
- •Weight loss of > 5% body weights
排除标准
- •Organic GI pathology
- •History of upper gi tract surgery
- •Major depression or anxiety
- •Use of antidepressants in the last 2 months
- •Prokinetic drugs or spasmolytic drugs
- •Analgesic use (except paracetamol)
- •Pregnancy or lactation
研究组 & 干预措施
Mirtazapine
Active Comparator
mirtazapine 15 mg daily
干预措施: Mirtazapine (Drug)
Placebo
Placebo Comparator
Placebo once daily
干预措施: Mirtazapine (Drug)
结局指标
主要结局
Difference in dyspepsia symptom scores week 8 versus week 0
时间窗: Week 8 compared to week 0
The Dyspepsia Symptom Score is calculated from the dyspepsia symptom severity questionnaire at weeks 0, 4 and 8. The symptom score has been used in previous studies (Tack et al., Gastroenterology 1998).
次要结局
- Individual symptom severities(Week 8 compared to week 0)
- Nepean dyspepsia index for quality of life in functional dyspepsia(Week 8 compared to week 0)
研究者
研究点 (1)
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