Health Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation
Conditions
Interventions
Intervention1: Non bismuth concomitant quadruple therapy: Tab Pantoprazole 40 mg BD
Tab amoxicillin 1 gm BD
Tab Clarithromycin 500 mg BD
Tab Metronidazole 400 mg TDS
given in group B Control group
Sponsors
Dr Yashdeep Yadav
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years and above. 2. Confirmed H. pylori infection by at least one positive test among: o Non-invasive tests ( Stool antigen test) o Invasive tests (Rapid Urease test (RUT) or Histopathology of gastric biopsy) 3. Treatment-na ve patients (no prior H. pylori eradication therapy). 4. Ability to give informed written consent.
Exclusion criteria
Exclusion criteria: 1. Previous H.Pylori eradication or use of antibiotics active against H.Pylori 2. Use of PPI ,H-2 receptor blockers or bismuth compounds within the preceding 2 weeks from testing 3.Known allergy to penicillin or any study drug component 4.Pregnancy or lactation 5.Severe hepatic , renal or cardiac disease 6. History of gastric surgery or malignancy 7. Non compliance anticipated or inability to attend follow up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether fexuprazan-amoxicillin dual therapy is non inferior to standard non bismuth concomitant quadruple therapy for first line eradication of Helicobacter pyloriTimepoint: 4 weeks after completion of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the H.Pylori eradication rates of fexuprazan amoxicillin dual therapy versus non bismuth quadruple therapy using ITT and PP analyses 2.To assess the safety and tolerability 3.To evaluate patient compliance 4.To explore fexuprazan pharmacologic advantagesTimepoint: 4 weeks after completion of therapy | — |
Countries
India
Contacts
Public ContactDr Yashdeep Yadav
Indira Gandhi Medical College And Hospital
Outcome results
None listed