Evaluation of Complete Remission of Erosive Gastroesophageal Reflux Disease Following Four-week Treatment With Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg With Eight-week Extension Treatment in Non-responding Patients - Multicenter, National, Prospective, Randomized, Double-blind, Parallel-group, Phase III
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 713
- 试验地点
- 1
- 主要终点
- Comparatively evaluation of the clinical efficacy of pantoprazole magnesium and esomeprazole in the treatment of patients with erosive gastroesophageal reflux disease (GERD), considering the proportion of patients in complete remission.
研究概览
简要总结
The aim of this trial is to evaluate the complete remission of erosive gastroesophageal reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once daily during four-week treatment with an extension treatment for non-responding patients. The study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28 -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux. The study will provide further data on safety and tolerability of pantoprazole magnesium.
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
- Double (Participant, Investigator)
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
- •Voluntary participation in the study with signature on Informed Consent Form (ICF) prior to specific protocol procedures
- •Patients of any race
- •On outpatient treatment
- •History of frequent symptom crises related to GERD within the last 3 months (at least a frequency of twice a week, for about four to eight weeks)
- •Diagnosis of erosive esophagitis (grade A to D, according to Los Angeles Classification)
- •In good health condition, except GERD symptoms
- •Able to follow the protocol directions and to complete daily the questionnaire ReQuest™ throughout the study
排除标准
- •Gastrointestinal disorder, even when related to chlorhydropeptic disorders: Barret's esophagus, peptic ulcer, Zollinger-Ellison syndrome and pyloric stenosis
- •Previous history of surgery to reduce acid secretion, or other upper gastrointestinal tract surgeries (excepting polypectomy and cholecystectomy)
- •At initial endoscopy presenting complicated disorders due to erosive esophagitis: obstructive esophageal stenoses, Schatzki ring, esophageal diverticulum, esophageal varices, achalasia and hiatal hernia
- •Pregnant women or during nursing period
- •Proton Pump Inhibitors (PPIs) within the last 10 days prior to start of the study
- •Triple therapy based on PPIs to eradicate H. pylori within the last 28 days prior to start of the study
- •H2-blockers, sucralfate and prokinetics within the last 7 days prior to start of the study
- •Systemic glucocorticoids and/or nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors) for more than 3 consecutive days a week, within the last 28 days prior to start of study, with exception of regular intake of acetyl salicylic acid in dosages of up to 163 mg/day.
研究组 & 干预措施
Magnesium Pantoprazole
干预措施: Magnesium Pantoprazole (Drug)
Magnesium Esomeprazole
干预措施: Magnesium Esomeprazole (Drug)
结局指标
主要结局
Comparatively evaluation of the clinical efficacy of pantoprazole magnesium and esomeprazole in the treatment of patients with erosive gastroesophageal reflux disease (GERD), considering the proportion of patients in complete remission.
时间窗: After 4 treatment weeks
A patient is considered at complete remission if he/she achieved symptoms relief and confirmed endoscopic healing at treatment end. A patient achieves symptoms relief if Reflux Questionnaire-GI score ((ReQuest™) stays below 1,73 for at least the three last consecutive treatment days, that can occur at visit V2 or visit V3 for those that did not achieve complete remission at V2 and repeated the treatment for 4 weeks more.
次要结局
- Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured(After 4 and 8 treatment weeks)
- Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
- Treatments comparative evaluation for endoscopic healing rate(After 4 and 8 treatment weeks)