Vonoprazan in Helicobacter Pylori Treatment an RCT

Sponsor

Dow University of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04901663

Collaborator

(none)

179

Enrollment

Location

Arms

1.8

Actual Duration (Months)

97.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG Drug: Vonoprazan 20 MG; Amoxicillin 1000 MG	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

179 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Control TrialRandomized Control Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 21, 2021

Actual Primary Completion Date :

Aug 13, 2021

Actual Study Completion Date :

Aug 16, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Helicobacter Pylori Eradication [4 weeks]
Stool Heliobacter Pylori Antigen = Negative

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.