Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Changing severity of heart burn of SSc related GERD evaluated by visual analogue score (VAS) Changing Severity of Heart Burn of SSc Evaluated by Visual Analogue Score (VAS)
研究概览
简要总结
Proton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •SSc patients aged between 18 and 65 years.
- •Clinically diagnosed as GERD
- •Must not receive any PPI or prokinetic drug within 2 weeks before baseline evaluation
排除标准
- •Pregnancy or lactation
- •Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
- •Present of Barrett's esophagus
- •Bedridden and confined to no self-care
- •Evidence of active malignant disease
- •Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases
- •Present of active infection that needs systemic antibiotic
- •Allergic history of omeprazole
- •Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
研究组 & 干预措施
proton pump inhibitor
omeprazole 20 mg twice daily
干预措施: Omeprazole 20mg (Drug)
结局指标
主要结局
Changing severity of heart burn of SSc related GERD evaluated by visual analogue score (VAS) Changing Severity of Heart Burn of SSc Evaluated by Visual Analogue Score (VAS)
时间窗: 4 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. PPI-PR GERD is defined when the changing of severity of heart burn is improvement less than 50% compare to baseline.
Changing of Frequency of Symptoms in SSc related GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)
时间窗: 4 weeks
Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment. PPI-PR GERD is defined when the changing of frequency of symptom in SSc related GERD evaluated by FSSG is improvement less than 50% compare to baseline.
次要结局
- The proportion of participant with diffuse cutaneous SSc (dcSSc) subset between the patient who response to omeprazole and partial response to omeprazole,(4 weeks)
- The proportion of participant with esophageal dysphagia between the patient who response to omeprazole and partial response to omeprazole,(4 weeks)
- The proportion of participant with female gender between the patient who response to omeprazole and partial response to omeprazole(4 weeks)
- The proportion of participant with modified Rodnan skin score (mRSS)>20 between the patient who response to omeprazole and partial response to omeprazole(4 weeks)
- The proportion of participant with serum anti-topoisomerase I antibody positive between the patient who response to omeprazole and partial response to omeprazole(4 weeks)
- The proportion of participant with age>60 years between the patient who response to omeprazole and partial response to omeprazole(4 weeks)
研究者
Chingching Foocharoen
Principle investigator
Khon Kaen University