Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: Vonoprazan 20 mg: One tablet once daily before breakfast on each morning up to 8 weeks.
Control Intervention1: Pantoprazole 40 mg: One tablet once daily before breakfast on each morning
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients aged of 18-65 years. 2. Patients willing to give written, signed, and dated informed consent to participate in the study. 3. Patients with established diagnosis of gastroesophageal reflux disease(GERD) with heartburn and/ or regurgitation of at least mild to severe intensity at least once a week. 4. Patients with gastroesophageal reflux disease and having Los Angeles Classification grade A-D. 5. Females of childbearing potential who are sexually active must agree to use barrier contraception and can neither be pregnant nor lactating from screening throughout the duration of the study and for 4 weeks after the last dose of study medication. 6. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to Vonoprazan or Pantoprazole or to any excipients of the products. 2. Patients receiving atazanavir sulphate, nelfinavir or rilpivirine hydrochloride. 3. Patients receiving any medications modifying gastric acid secretion such as oral antacids, PPIs etc., one week prior to randomization. 4. Patients receiving or requiring methotrexate during the study period 5. Patients with history of osteoporosis or hypomagnesemia 6. Patients with co-morbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures), a history of radiotherapy or cryotherapy for the esophagus; those with corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki’s ring or Barrett’s esophagus). 7. Patients with history of surgical procedures that may affect the esophagus (eg, fundoplication and mechanical dilatation for esophageal strictures excluding Schatzki’s ring) or a history of gastric or duodenal surgery excluding endoscopic removal of benign polyps. 8. Patients with acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days from Visit 1 (with the possible inclusion of those with gastric or duodenal erosion). 9. Patients requiring NSAIDs or aspirin treatment along with the concomitant PPI therapy. 10. Patients with Zollinger-Ellison syndrome or gastric acid hypersecretion or a history of gastric acid hypersecretion. 11. Patients on concomitant medications known to prolong QT interval. 12. Patients with abnormal laboratory evaluation results including a. Creatinine levels: > 1.5 X Upper Limit of Normal (ULN). b. ALT, AST or ALP levels: > 2.5 X ULN c. Serum Bilirubin levels: > 1.5 X ULN 13. Positive history for AIDS or hepatitis, including hepatitis virus carriers: HBs-antigen positive or HCV-antibody-positive. 14. History of alcohol or drug abuse in the last 6 months 15. Any psychiatric or mental disease compromising the ability to give the consent for participation in the study. 16. Patients who are currently participating in another investigational study or has participated in an investigational study within 90 days prior to randomization. 17. Any major cardiovascular, pulmonary, hematologic, hepatic, renal, metabolic, gastrointestinal (other than GERD) or endocrine disorder that may impact outcome of study based on investigator discretion. 18. Any other serious disease or condition at screening (or randomization) that would compromise patient safety, might affect life expectancy, or make it difficult to successfully manage and follow the patient according to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with Endoscopically-confirmed healing after 8 weeks in Gastroesophageal Reflux Disease (GERD) patients.Timepoint: After 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in GERD-FSSG score from baseline to end of 4 weeks. Change in GERD-FSSG score from baseline to end of 8 weeks Proportion of patients with complete resolution of heartburn and regurgitation after 4 weeks and 8 weeks. Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: After week 4 and week 8 | — |
Countries
India
Contacts
Public ContactDr Subhadeep Sinha MD
Hetero Labs Limited
Outcome results
None listed