NCT02670642已完成3 期
On Demand vs Continuous Treatment of Endoscopy Negative Subjects With Gastroesophageal Reflux Disease (GERD) With Esomeprazole 20-mg Once Daily Over a 6 Months Long Term Treatment Phase. An Open, Randomised, Multicenter Study. NEED.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 877
- 试验地点
- 60
- 主要终点
- Difference between the proportion of patients who discontinued on-demand esomeprazole treatment versus continuous esomeprazole treatment due to unsatisfactory treatment as determined by the investigator in consultation with the patient
研究概览
简要总结
The purpose of this study is to compare on demand with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms suggestive of GERD, with heartburn as their predominant symptom (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck), for longer than 6 months.
- •Heartburn occurring for 4 days or more during the last 7 days prior to endoscopy. Or, if PPI treatment has been started within the last 7 days prior to endoscopy, then heartburn occurring for 4 days or more during the last 7 days prior to start of PPI treatment
- •Male or female, at least 18 years of age (for Austria, at least 19 years of age)
- •Have given written informed consent
- •Ability to read and write (literate)
- •7 symptom free (from heartburn) days in the last week prior to randomisation (day of visit not included)
排除标准
- •Documented esophageal mucosal break
- •History of esophageal, gastric or duodenal surgery, except closure and oversewing of an ulcer
- •Chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating, that in the opinion of the investigator is likely to be due to irritable bowel syndrome or two or more of the following criteria:
- •Symptoms relieved by defecation
- •Symptoms associated with change in frequency of stools
- •Symptoms associated with change in form of stools
- •Any significant "alarm symptoms" such as unintentional weight loss, haematemesis melaena, jaundice or any other sign indicating serious or malignant disease.
- •Subjects with current or historical evidence of the following diseases/conditions
- •Zollinger Ellison syndrome
- •Primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal spasm
- •Complications of GERD such as esophageal stricture, ulcer and/or macroscopic Barrett's metaplasia (longer than 3 centimetres) or significant dysplastic changes in the esophagus
- •Evidence of upper gastrointestinal malignancy at the screening endoscopy
- •Gastric and/or duodenal ulcers within the last 2 years
- •Malabsorption
- •Malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator
- •Unstable diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable
- •Cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or embolus
- •Subjects using a PPI for more than 10 days in the last 28 days, prior to endoscopy
- •Use of PPIs for more than 5 days in the last 7 days prior to endoscopy
- •Subjects using daily H2-receptor antagonist, prokinetics recommended in the treatment of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the endoscopy and visit 1 and throughout the study
- •Need for continuous concurrent therapy with
- •NSAIDs (including selective COX II antagonists, salicylates (unless<165 mg daily for cardiovascular prophylaxis)
- •anticholinergics
- •prostaglandin analogues
- •phenytoin
- •ketoconazole
- •itraconazole
- •warfarin and other vitamin K antagonists
- •Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator (for Austria: Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to entry and then at monthly basis. For South-Africa and Spain:
- •Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to endoscopy)
- •Use of any other investigational compound 28 days prior to start and during the study
- •Requirement of an interpreter (illiterate)
- •Alcohol and/or drug abuse or any condition associated with poor compliance, including expected non-co-operation, as judged by the investigator
- •Previous participation in this study
- •Contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and any other constituents of the formulation. Known hypersensitivity to substituted benzimidazole
研究组 & 干预措施
On demand 20 mg esomeprazole
Experimental
On demand treatment with 20-mg esomeprazole once daily when needed
干预措施: Esomeprazole (Drug)
Continuous 20 mg esomeprazole
Active Comparator
Continuous treatment with 20 mg esomeprazole once daily
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Difference between the proportion of patients who discontinued on-demand esomeprazole treatment versus continuous esomeprazole treatment due to unsatisfactory treatment as determined by the investigator in consultation with the patient
时间窗: 6 months
Compare on demand (taken as needed by the patient to adequately control their reflux disease) with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief
次要结局
- Change from baseline in impact of reflux symptoms on health-related quality of life using pre-specified dimensions of the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire(6 months)
- Difference between the proportion of patients reporting treatment satisfaction with on-demand versus continuous esomeprazole treatment assessed by standard patient-completed electronic questionnaire at clinical visits and premature discontinuation(6 months)
- Frequency of adverse events and assessment of hematology (hemoglobin, leukocytes, thrombocytes) and clinical chemistry (creatinine, alkaline phosphate, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, total bilirubin)(6 months)
- Individual patterns of esomeprazole tablet usage measured using the Medical Event Monitoring System (MEMS) container (date and time of use recorded)(6 months)
- Reasons for discontinuation of on-demand or continuous esomeprazole treatment assessed by investigator-completed questionnaire at clinical visits(6 months)
- Mean number of esomeprazole tablets taken measured using the Medical Event Monitoring System (MEMS) container (date and time of use recorded)(6 months)
- Change from baseline in impact of reflux symptoms on health-related quality of life using pre-specified dimensions of the Quality Of Life in Reflux And Dyspepsia (QOLRAD) questionnaire(6 months)
研究者
研究点 (60)
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