The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)
研究概览
简要总结
The investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omeprazole plus alginic acid and placebo of domperidone
干预措施: placebo (for domperidone) (Drug)
Omeprazole plus alginic acid and placebo of domperidone
干预措施: Alginic acid (Drug)
Omeprazole plus domperidone and placebo of alginic acid
干预措施: Domperidone (Drug)
Omeprazole plus domperidone and placebo of alginic acid
干预措施: placebo (of alginic acid) (Drug)
结局指标
主要结局
Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)
时间窗: 8 weeks
VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment.
Changing of the Severity of Regurgitation
时间窗: 8 weeks
VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment.
次要结局
- Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)(8 weeks)
- the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole(4 weeks)
- Changing of the Quality of Life Which is Evaluated by EQ-5DTM(8 weeks)
研究者
Chingching Foocharoen
Associate Professor
Khon Kaen University