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

Sponsor

Aga Khan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05728424

Collaborator

Searle Pharmaceuticals (Other)

246

Enrollment

Location

Arms

7.3

Anticipated Duration (Months)

33.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.
To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Vonoprazan, Amoxicillin, Levofloxacin	Phase 3

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

246 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 20, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 weeks vonoprazan containing triple regimen For two weeks: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily	Drug: Vonoprazan, Amoxicillin, Levofloxacin No additional information
Placebo Comparator: 1 week vonoprazan containing triple regimen For One week: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily For the second week: Placebo	Drug: Vonoprazan, Amoxicillin, Levofloxacin No additional information

Arm

Intervention/Treatment

Active Comparator: 2 weeks vonoprazan containing triple regimen

For two weeks: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily

Drug: Vonoprazan, Amoxicillin, Levofloxacin

No additional information

Placebo Comparator: 1 week vonoprazan containing triple regimen

For One week: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily For the second week: Placebo

Drug: Vonoprazan, Amoxicillin, Levofloxacin

No additional information

Outcome Measures

Primary Outcome Measures

Efficacy of triple therapy in eradication of H.pylori (based on duration) [6 months]
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.

Secondary Outcome Measures

Quality of life assessment using QoLRAD (quality of life in reflux and dyspepsia) [6 months]
b) To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aga Khan University Hospital	Karachi	Sindh	Pakistan

Sponsors and Collaborators

Aga Khan University
Searle Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SHAHAB ABID, Professor Of Medicine, Aga Khan University

ClinicalTrials.gov Identifier:

NCT05728424

Other Study ID Numbers:

2022-7002-21047

First Posted:

Feb 15, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Amoxicillin

Levofloxacin

Ofloxacin

Study Results

No Results Posted as of Feb 15, 2023