Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: Vonoprazan 20mg: One tablet of Vonoprazan 20 mg should be taken orally once a day in the morning at the same
time after the meal.
Control Intervention1: Not Applicable: Not Applicable
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 Reflux esophagitis (RE)/Gastric Ulcer (GU)/Duodenal Ulcer (DU)/prevention of gastric ulcer or duodenal ulcer during low dose aspirin/administration and NSAIDs administration/adjunct to helicobacter pylori eradication associated with gastric ulcer, duodenal ulcer/ gastric MALT (mucosa-assisted lymphoid tissue) lymphoma, idiopathic thrombocytopenia purpura/ stomach after endoscopic resection of early stage cancer or helicobacter pylori gastritis. 4. Patients (Women of childbearing potential and their partners) must agree to use barrier contraception during the study period and for 3 months afterward and neither become pregnant or lactate.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent clinical & laboratory adverse events (TEAEs) during the treatment period.Timepoint: At the end of the Week 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in GERD-FSSG score from baseline to end of 4 weeks. Timepoint: week 4;2. Change in GERD-FSSG score from baseline to end of 8 weeks. Timepoint: Week 8;3. Proportion of patients with complete resolution of heartburn and regurgitation after 4 weeks and 8 weeks.Timepoint: week 4 & week 8 | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Labs Limited
Outcome results
None listed