Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication (P-CABs)

October 24, 2023 updated by: Reda Elwakil, Ain Shams University

Efficacy of Potassium Competitive Acid Blockers (P-CABs) Versus Proton Pump Inhibitors (PPIs) in the First and the Second Lines Eradication Regimens for H. Pylori in Egyptian Patients

This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11341
        • Faculty of Medicine Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age above 18 years of both genders.
  • Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.
  • Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).
  • Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).
  • Patients signing an informed consent.

Exclusion Criteria:

  • Patients refusing to sign an informed consent.
  • Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .
  • Patients who have chronic debilitating and advanced systemic diseases.
  • Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.
  • Any lactating or pregnant female.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 Vonoprazn Triple Therapy Arm
Fifty eight participants.The patients received (Clarithromycin 500 mg tablets twice daily[BID]+ Amoxicillin 1gm capsules BID + Vonoprazan 20 mg tablets BID) for 14 days
Drug: Vonoprazan
Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily
Other Names:
  • Levofloxacin
  • Clarithromycin
  • Nitazoxanide
  • Esomeprazole
  • Amoxycillin
  • Doxycicline
Active Comparator: Arm 2 Proton Pump Inhibitor Triple Therapy Arm
Fifty eight participants.The patients received the classic triple therapy (Clarithromycin 500 mg tablets BID + Amoxicillin 1gm capsules BID + Esomeprazole 20 mg tablets BID) for 14 days
Drug: Vonoprazan
Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily
Other Names:
  • Levofloxacin
  • Clarithromycin
  • Nitazoxanide
  • Esomeprazole
  • Amoxycillin
  • Doxycicline
Experimental: Arm 3 Vonoprazan Quadruple Therapy Arm
Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets once daily[OD] + Vonoprazan 20mg tablets BID + Nitazoxanide 500mg tablets BID +Doxycycline 100mg capsules OD) for 14 days.
Drug: Vonoprazan
Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily
Other Names:
  • Levofloxacin
  • Clarithromycin
  • Nitazoxanide
  • Esomeprazole
  • Amoxycillin
  • Doxycicline
Active Comparator: Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm
Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets OD + Esomeprazole 20mg tablets BID + Nitazoxanide 500 mg tablets BID +Doxycycline 100mg capsules OD) for 14 days
Drug: Vonoprazan
Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily
Other Names:
  • Levofloxacin
  • Clarithromycin
  • Nitazoxanide
  • Esomeprazole
  • Amoxycillin
  • Doxycicline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H.pylori eradication
Time Frame: six weeks
The rate of the patients who achieved H.pylori eradication as measured by negative H.Pylori stool antigen test in the four arms of the study was reported.
six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Vonoprazan use
Time Frame: six weeks
The number of patients who reported minor and major treatment connected adverse events in the four arms of the study was reported.
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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