NCT05728424

One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL

ONE WEEK VS. TWO WEEKS VONOPRAZAN CONTAINING TRIPLE REGIMEN FOR ERADICATION OF HELICOBACTER PYLORI:

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan. 2. To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.

Detailed description

Introduction: The overall aim of the study is to assess the efficacy of one week of Vonoprazan compared to two weeks of Vonoprazan in eradicating H-Pylori in patients with dyspeptic symptoms. H. pylori is a pathogenic Gram-negative spiral bacillus that survives in the acid environment of the stomach. It is a leading cause of chronic gastritis, peptic ulcers, non-ulcer dyspepsia, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. It is estimated that up to 50% of the total world population are infected with H. pylori. The prevalence of H. Pylori infection is currently rising in the developing world. Modified one-week triple therapy (two antibiotics for a week and a potassium-competitive acid blocker for 4-8 weeks) represents the most advanced prescribed regimen for H. pylori infection. With current and widely used therapeutic regimens, (such as two antibiotics and a proton pump inhibitor) there is a significant failure rate for the eradication of microorganism. Therefore, interventions that can improve H-pylori eradication along with improving patient's quality of life are highly important. Vonoprazan is a potassium-competitive acid blocker, which inhibits the H+/K+ pump in the stomach. Unlike proton pump inhibitors, Vonoprazan inhibits the pump in a competitive and reversible manner. Hence, it is expected to be at least as effective as PPIs in the elimination of Helicobacter Pylori. Assessing the duration of Vonoprazan based triple therapy is of great concern.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Vonoprazan, Amoxicillin, Levofloxacin	No additional information

Timeline

• Start date: 2022-09-20
• Primary completion: 2023-04-01
• Completion: 2023-05-01
• First posted: 2023-02-15
• Last updated: 2023-02-15

Locations

1 site across 1 country: Pakistan