ACTRN12607000006448已完成4 期
A multicentre, double blind, randomised controlled non-inferiority study to compare the number of subjects with gastro-oesophageal reflux disease achieving heartburn and regurgitation symptom resolution after treatment with either Rabeprazole Sodium (PARIET) 20mg, Esomeprazole (NEXIUM) 20mg or Esomeprazole (NEXIUM) 40mg
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,908
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1. Able to give written informed consent. 2. Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or lower part of the chest up towards the neck) with or without regurgitation. To be eligible, subjects must have had episodes of heartburn with or without regurgitation for 3 months or longer, and for > 3 days in the 7 days prior to randomisation. 3. Able to understand and complete questionnaires and have access to a telephone. 4. Helicobacter pylori testing is allowed provided that it is not critical to a PPI-prescribing decision and(a) The results of the test must not be divulged to the subject(b) No interventions as a result of the test occur until after the subject’s participation in the study.
排除标准
- •1. Subjects requiring endoscopy within 4 weeks of randomisation or with gastrointestinal symptoms that, in the opinion of the investigator, require further investigation prior to or coincident with initiation of PPI therapy. These would include, but are not limited to, alarm symptoms such as unintentional weight loss, progressive difficulty swallowing (dysphagia), iron deficiency anaemia and epigastric mass.2. Significant gastrointestinal disease active in the last 12 months including:i) GI bleedingii) Gastroduodenal ulceriii) Infectious or inflammatory conditions of the intestineiv) Functional dyspepsiav) Malabsorption syndromesvi) Gastrointestinal obstructionvii) Major gastric or oesophageal surgery (excluding appendicectomy or cholecystectomy)viii) Oesophageal stricture or pyloric stenosisix) Extra-oesophageal manifestations of reflux disease3. Barrett's oesophagus (>3cm)4. Zollinger-Ellison Syndrome5. Scleroderma6. Malignancy (other than non-melanoma skin cancers) present within the last 5-years7. Subjects with a known hypersensitivity to rabeprazole or esomeprazole or any PPI8. Female subjects who are currently pregnant or breastfeeding, or who, in the opinion of the investigator, may become pregnant throughout the study9. Use of:i) histamine-2 receptor antagonists (H2RAs) within 7 days of randomisationii) anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, proton pump inhibitors (PPIs), prokinetics, antibiotics (in relation to H.pylori treatment) or bismuth compounds within 14 days of randomisation.Note – subjects on stable doses of anticholinergics, cholinergics, spasmolytics, opiates and NSAIDs are eligible for entry (where stable dose is defined as one unchanged for > 1 month prior to screening)iii) any drug contra-indicated for use with PPIs10. Any other significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study e.g. past or current history of alcohol or drug abuse, hepatic, renal, pulmonary, respiratory abnormalities etc11. Subjects who are unwilling or unable to abide by the requirements of the study (e.g. completion of daily diary, attendance at study visits)12. Subjects who have participated in an investigational drug or investigational device study within 30 days prior to the baseline visit or who are expected to do so during the 4 week study period.
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