Vonoprazan in Helicobacter Pylori Treatment an RCT

August 17, 2021 updated by: Bader Faiyaz Zuberi, Dow University of Health Sciences

Comparison of Vonoprazan and Amoxicillin Dual Therapy With Standard Triple Therapy With Proton Pump Inhibitor for Helicobacter Pylori Eradication; a Randomized Control Trial

RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori erradication with Vonoprazan+Amoxil dual therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE To compare the efficacy of Vonoprazan based dual treatment versus PPI based treatment for the eradication of Helicobacter pylori infection.

OPERATIONAL DEFINITION

Helicobacter Pylori infection: Hp infection will be labelled by any one of following investigation:

  • Helicobacter Pylori Stool Antigen
  • Histopathology on Giemsa Stain

MATERIAL AND METHODS:

Study Design: Randomized control trial. Setting: This study will be conducted in the Medical OPD and Medical Unit 1 of Dr. Ruth K.M. Pfau, Civil Hospital Karachi affiliated with Dow University of Health Sciences

DATA COLLECTION PROCEDURE:

All patients presenting to the OPD or Medical Unit 1 of Dr. Ruth KM Pfau, Civil Hospital Karachi and fulfilling the inclusion criteria will be included after taking informed consent.

The participants will be randomly allocated to 2 groups with help of random number table and will be treated for 2 weeks.

Group A: will be given:

Capsule Amoxicillin 1 gm twice daily Tablet Clarithromycin 500 mg twice a day Capsule Omeprazole 20 mg twice a day

Group B will be given:

Capsule Amoxicillin 1 gm twice daily Tablet Vonoprazan 20 mg twice a day Confirmation of Hp eradication will be done by stool Hp antigen test 4 weeks after completion of treatment.

DATA ANALYSIS Data will be stratified according to age & gender. Frequency of gender & mean (SD) of age will be compared between groups using Pearson's Chi-square test and Student's t-test respectively. Frequency of Hp eradication between two groups will be compared using Pearson's chi-square test. A p value < .05 will be taken as significant.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 4

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

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74400
        • Dr Ruth KM Pfau civil hospital karachi

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Helicobacter Pylori Positive by any one of following:

Histopathology by Giemsa Stain Stool Antigen

Exclusion Criteria:

  • • Previous surgery of the stomach such as partial gastrectomy.

    • Allergy to any of the antibiotics used in the study.
    • Intake of antibiotics, PPIs, corticosteroids, or nonsteroidal anti-inflammatory drugs within the last 2 weeks.
    • Pregnant or lactating females.
    • Alcohol abuse or drug addiction.
    • Severe neurological or psychiatric disorder.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omeprazole Group
Omeprazole 20 mg BD Amoxicillin 1000 mg BD Clarithromycin 500 mg BD
Drug: Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG
Orally twice daily for 2 weeks
Other Names:
  • Omeprazole Group
Experimental: Vonoprazan Group
Vonoprazan 20 mg BD Amoxicillin 1000 mg BD
Drug: Vonoprazan 20 MG; Amoxicillin 1000 MG
Orally twice daily for 2 weeks
Other Names:
  • Vonoprazan Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter Pylori Eradication
Time Frame: 4 weeks
Stool Heliobacter Pylori Antigen = Negative
4 weeks

Collaborators and Investigators

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

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Bader F Zuberi, FCPS, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 21, 2021

Primary Completion (Actual)

August 13, 2021

Study Completion (Actual)

August 16, 2021

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAD-VPZ-001

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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