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The Effect of Rebamipide for the Patients with Reflux Esophagitis and Gastritis

基本情報

進捗状況	試験終了
対象疾患	Phase IV, multi-center, randomized, open-labeled, comparison study
試験開始日（予定日）	2011-11-01
目標症例数	492
臨床研究実施国	アジア（日本以外）
研究のタイプ	介入

試験の内容

介入1	Intervention group is treated by rebamipide and esomeprazole
介入2	Control group is treated by esomeprazole
主要アウトカム評価項目	Improvement of a total symptom score after four-week administration of esomeprazole and rebamipide
副次アウトカム評価項目	The mean decrease in the total symptom score at 4 weeks since trial medicine, the change from baseline of reflux symptoms (heartburn and regurgitation), the proportion of patients with at least a 50% decrease in the symptoms score compared with their baseline score, and the proportion of patients reporting complete improvement of symptoms

対象疾患

年齢（下限）
年齢（上限）
性別	3
選択基準	1) Adults aged over 20 years and less 70 years 2) Patients diagnosed as reflux esophagitis through esophagogastroduodenoscopy 3) Patients signing the informed consent document of this clinical study
除外基準	1) Pregnant or lactating women, child bearing women not using a proper contraception 2) Patients with history of gastrointestinal surgery 3) Patients with gastric ulcer or duodenal ulcer 4) Patients with significant impairment in the heart, the lung, the blood or the endocrine system 5) Patients with psychiatric disorders or alcohol or drug addiction 6) Patients who are considered to be unsuitable by investigator(s) because of other reason