Skip to main content
OpenTrials
Completed

NCT Number: NCT04901663

Vonoprazan in Helicobacter Pylori Treatment an RCT

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr Ruth KM Pfau Civil Hospital Karachi

Karachi, Sindh, 74400, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG

Drug

Orally twice daily for 2 weeks

Other names: Omeprazole Group

Vonoprazan 20 MG; Amoxicillin 1000 MG

Drug

Orally twice daily for 2 weeks

Other names: Vonoprazan Group

Primary outcomes

  1. Helicobacter Pylori Eradication

    Time frame: 4 weeks

    Stool Heliobacter Pylori Antigen = Negative

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 25, 2021
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.