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Comparing Vonoprazan and Omeprazole for Healing Stomach Ulcers

Efficacy and Safety of Vonoprazan versus Omeprazole in Pharmacotherapy of H. pylori-Induced Peptic Ulcer in Eastern India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091209
Enrollment
100
Registered
2025-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation

Interventions

Intervention1: Vonaprazan: Intervention drugs: Vonoprazan 20mg + Amoxicillin 750 mg + Metronidazole 400mg twice daily for 14 days, PO Control Intervention1: Omeprazole: Omeprazole 20mg + Amoxicillin

Sponsors

Dr Bazla Nazir
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to provide informed consent and adhere to study protocols. Patients with a confirmed diagnosis of H. pylori infection via urea breath test, stool antigen test, or histological examination.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of allergy or intolerance to vonoprazan, omeprazole, or related compounds. 2.Patients currently using other proton pump inhibitors or H2 receptor antagonists within 2 weeks before the study. 3.Patients with a history of gastric surgery or previous H. pylori eradication therapy. 4.Patients with severe comorbidities such as liver, kidney, or heart diseases. 5.Pregnant or lactating women. 6.Patients unable or unwilling to comply with study procedures and follow-up visits

Design outcomes

Primary

MeasureTime frame
The proportion of patients achieving clinical cure (resolution of peptic ulcer symptoms) at the end of pharmacotherapy (14th day) for Vonoprazan triple therapy compared to Omeprazole triple therapy.Timepoint: 2 weeks

Secondary

MeasureTime frame
H. pylori eradication (negative UBT and RUT post-treatment)Timepoint: baseline and 2 weeks;Endoscopic grading (Forrest Classification)Timepoint: baseline and 2 weeks;quality of life assessment using validated tool: SF-36Timepoint: 2 weeks;Incidence of adverse effects using WHO UMC causality assessment scalesTimepoint: baseline to 2 weeks

Countries

India

Contacts

Public ContactDr Bazla Nazir

Indira Gandhi Institute Of Medical Sciences

manu072@gmail.com9304093698

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026