NCT00444275已完成4 期
A Randomized, Open, Parallel-group Study to Evaluate the Efficacy of Three Different Patient Management Strategies During a 12 Weeks Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,029
- 试验地点
- 1
- 主要终点
- Efficacy of Three Strategies of Long-term Treatment
研究概览
简要总结
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).
排除标准
- •Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit
- •A history of severe esophagitis or known other complications, with alarm symptoms
研究组 & 干预措施
Esomeprazole 20 mg Once Daily (initial phase)
Experimental
干预措施: esomeprazole (Nexium®) (Drug)
Esomeprazole 40 mg Once Daily (initial phase)
Experimental
干预措施: esomeprazole (Nexium®) (Drug)
Esomeprazole 20 mg Once Daily (Maintenance Phase)
Experimental
干预措施: esomeprazole (Nexium®) (Drug)
Esomeprazole 20 mg on Demand (Maintenance Phase)
Experimental
干预措施: esomeprazole (Nexium®) (Drug)
Antacid Treatment (Maintenance Phase)
Experimental
干预措施: Xolaam® (Drug)
结局指标
主要结局
Efficacy of Three Strategies of Long-term Treatment
时间窗: 16 weeks
Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?
次要结局
- Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).(4 weeks)
- Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase(4 weeks)
- Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)(4 to 16 weeks)
- Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment(16 weeks)
- Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study(12 weeks - maintenance treatment phase)
- Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire(Day 0)
- Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)(Week 4)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Esomeprazole (NEXIUM) vs. SurgeryGastroesophageal RefluxNCT00251927AstraZeneca626
已完成
3 期
Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux DiseaseGastroesophageal Reflux DiseaseNCT01400945Ahn-Gook Pharmaceuticals Co.,Ltd154
尚未招募
不适用
The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.Proximal Early Gastric CancerNCT06511609Changzhi People's Hospital Affiliated to Changzhi Medical College244
已完成
不适用
Comparative Anti-Reflux Procedures in Neurologically Impaired ChildrenNervous System DiseasesFundoplicationEnteral NutritionGastroesophageal RefluxNCT01307982University of Utah3
Unknown
不适用
Comparison of Treatment Outcome and Cost-effectiveness for GERDGastroesophageal RefluxNCT03661151Sungsoo Park100