Gastro-Esophageal Reflux Disease MedDRA version: 19.0 Level: PT Classification code 10017885 Term: Gastrooesophageal reflux disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: TAKECAB
Product Name: Vonoprazan
Product Code: TAK-438
Pharmaceutical Form: Capsule
INN or Proposed INN: vonoprazan
Sponsors
Takeda Development Centre Europe Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in subjects who have a partial response to treatment with esomeprazole;Secondary Objective: To determine the effect of vonoprazan treatment on sustained resolution of heartburn symptoms over a 4-week treatment period (at least one 7-day symptom-free period);Primary end point(s): Percentage of heartburn-free 24 hour periods (day and night) during 4 weeks of randomized double-blind treatment.;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects with =1 sustained resolution of heartburn (defined as =7 consecutive days without both daytime and nighttime heartburn any time during the 4-week randomized double-blind Treatment Period).;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Countries
Belgium, Czech Republic, Estonia, United Kingdom
Contacts
Public ContactDr. Richard J. Jenkins
Takeda Development Center Europe Ltd
Outcome results
None listed