NCT04901663

Vonoprazan in Helicobacter Pylori Treatment an RCT

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Dow University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG	Orally twice daily for 2 weeks
DRUG	Vonoprazan 20 MG; Amoxicillin 1000 MG	Orally twice daily for 2 weeks

Timeline

• Start date: 2021-06-21
• Primary completion: 2021-08-13
• Completion: 2021-08-16
• First posted: 2021-05-25
• Last updated: 2021-08-18

Locations

1 site across 1 country: Pakistan