Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management

NCT05614934 | Completed Phase 4 DMC

• 1 other identifier: 0107175
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens. The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori; vonoprazan; standard triple therapy

Outcome Measures

Primary Outcomes (1)

• Determination of the eradication rates for each regimen

  Percentage eradication in each group is calculated by intention-to-treat analysis or per-protocol analysis.

  1.5 month

Secondary Outcomes (2)

• Determination of number of compliant participants to each regimen

  1.5 month

• Determination of number of participants with treatment related adverse events

  2 weeks

Study Arms (3)

S3

ACTIVE COMPARATOR

Standard clarithromycin triple

Drug: standard Clarithromycin triple therapy

V3

EXPERIMENTAL

Vonoprazan triple

Drug: Vonoprazan triple therapy

V2

EXPERIMENTAL

Vonoprazan dual

Drug: Vonoprazan dual therapy

Interventions

standard Clarithromycin triple therapy DRUG

Oral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days

S3

Vonoprazan triple therapy DRUG

Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days

V3

Vonoprazan dual therapy DRUG

Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days

V2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with positive stool antigen test result for H. pylori
• Patients recently diagnosed with H. pylori infection and did not receive any treatment

You may not qualify if:

• Patients sensitive to any of the regimens' components
• Patients who had received a previous eradication therapy and still show positive test results
• Recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month
• Patients with gastric malignancy or who underwent previous gastric surgery
• Pregnancy and lactation
• Patients with major concomitant diseases, including psychic disorders

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University outpatient clinics

Alexandria, Egypt

Location

Related Publications (1)

• Shekeban YM, Hamdy NA, Header DA, Ahmed SM, Helmy MM. Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial. Sci Rep. 2025 May 8;15(1):15989. doi: 10.1038/s41598-025-98606-8.

  PMID: 40341536 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant at clinical pharmacy and pharmacy practice department, faculty of pharmacy Alexandria University

Model Details: Open-labeled, prospective, three-arm, parallel-group, non-placebo Randomized controlled clinical trial

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: June 11, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 15, 2023
• Last Updated: February 21, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)