Clinical trial NCT04901663: Vonoprazan in Helicobacter Pylori Treatment an RCT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: helicobacter pylori
Vonoprazan
potassium-competitive acid inhibitor
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Helicobacter Pylori Eradication
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr Ruth KM Pfau Civil Hospital Karachi
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Bader F Zuberi, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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