A Randomized, Double-Blind, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once Daily Oral Vonoprazan 20 mg or Vonoprazan 40 mg Compared to Esomeprazole 40 mg for the Treatment of Subjects With Symptomatic Gastro-Esophageal Reflux Disease Who have a Partial Response Following Treatment with a High Dose of Proton Pump Inhibitor

Takeda Development Centre Europe Ltd0 个研究点目标入组 213 人开始时间: 2016年9月6日最近更新: 2018年12月4日

适应症

试验速览

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•Subjects will be eligible for participation in the study if they:
•-have a documented history of symptoms of both heartburn and acid regurgitation prior to entry into the study
•- have a history of persistent heartburn and/or regurgitation symptoms that are troublesome despite an adequate course of PPI treatment;
•- continue to have symptoms of heartburn (and regurgitation) following 4 weeks treatment with a high dose of esomeprazole 40 mg QD during the Run-in Period;
•- have symptoms of heartburn which increases following a 2-week Washout Period in the presence of regurgitation prior to randomization. Patients with mild (LA grade A) esophagitis are permitted to enter the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 181
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

•- Subjects who have hypersensitivity to vonoprazan or related compounds
•- a history or any coexisting diseases affecting the esophagus;
•-‘alarm features’ in symptomatology pointing to a possible malignant disease of the GI tract;
•- current or historical chest pain due to cardiac disease;
•-a history of surgical treatment for GERD;
•- dilation of an esophageal stricture or gastric or duodenal surgery.
•- Subjects who have a documented history of functional dyspepsia or irritable bowel syndrome or other gastrointestinal diseases which are not acid-related, and therefore, are nonresponsive to gastric acid-blocking treatment.
•- Subjects who have levels of AST,ALT or total bilirubin > ULN.
•- those who have a documented history of familial adenomatous polyposis, active gastric or duodenal ulcers or acute upper gastrointestinal hemorrhage within 30 days prior to screening and any other co-morbidities or any significant results from physical examinations, or clinical laboratory results as deemed by the investigator.

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