Vonoprazan in Helicobacter Pylori Treatment an RCT

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Vonoprazan 20 MG; Amoxicillin 1000 MG; Drug: Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG

• Registration Number: NCT04901663
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-25
• Study Start: 2021-06-21
• Status Verified: 2021-08
• Primary Completion: 2021-08-13
• Study Completion: 2021-08-16
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vonoprazan Group	Vonoprazan 20 MG; Amoxicillin 1000 MG	Vonoprazan 20 mg BD Amoxicillin 1000 mg BD
Omeprazole Group	Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG	Omeprazole 20 mg BD Amoxicillin 1000 mg BD Clarithromycin 500 mg BD

Primary Outcome Measures

Name	Time	Method
Helicobacter Pylori Eradication	4 weeks	Stool Heliobacter Pylori Antigen = Negative

Trial Locations

Locations (1)

Dr Ruth KM Pfau Civil Hospital Karachi; 🇵🇰 Karachi, Sindh, Pakistan