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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728424
• Other study ID #: 2022-7002-21047
• Status: Recruiting
• Phase: Phase 3
• Start date: September 20, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2023
• Source: Aga Khan University
• Contact: Shahab abid, MBBS, PhD
• Phone: 923333965940
• Email: shahab.abid[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• H pylori infection confirmed by any of the 3 tests C-urea breath test (UBT), , rapid urease test, and stool H pylori antigen.

Exclusion Criteria:

• acute gastrointestinal disease (e.g., acute diarrhea)

• chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)

• known renal and/or liver failure

• no known malignancy

• varices bleeding

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Vonoprazan, Amoxicillin, Levofloxacin
No additional information

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	Searle Pharmaceuticals

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of triple therapy in eradication of H.pylori (based on duration)	a) 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.; The eradication of H.pylori will be tested using the Urea breath test 6 weeks post treatment.	6 months
Secondary	Quality of life assessment using QoLRAD (quality of life in reflux and dyspepsia)	b) To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.	6 months