Comparison of Vonoprazan to Esomeprazole in Subjects with Symptomatic GERD Who Responded Partially to a High Dose of PPI

Phase 1

Conditions: Gastro-Esophageal Reflux Disease
MedDRA version: 20.1Level: PTClassification code 10017885Term: Gastrooesophageal reflux diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2015-001154-14-CZ

Lead Sponsor: Takeda Development Centre Europe Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 213

Inclusion Criteria

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

Exclusion Criteria

- 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.