Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

NCT ID: NCT06101420

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-01

Brief Summary

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This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori

Detailed Description

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The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.

Conditions

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Helicobacter Pylori Eradication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 Vonoprazn Triple Therapy Arm

Fifty eight participants.The patients received (Clarithromycin 500 mg tablets twice daily\[BID\]+ Amoxicillin 1gm capsules BID + Vonoprazan 20 mg tablets BID) for 14 days

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily

Arm 2 Proton Pump Inhibitor Triple Therapy Arm

Fifty eight participants.The patients received the classic triple therapy (Clarithromycin 500 mg tablets BID + Amoxicillin 1gm capsules BID + Esomeprazole 20 mg tablets BID) for 14 days

Group Type ACTIVE_COMPARATOR

Vonoprazan

Intervention Type DRUG

Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily

Arm 3 Vonoprazan Quadruple Therapy Arm

Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets once daily\[OD\] + Vonoprazan 20mg tablets BID + Nitazoxanide 500mg tablets BID +Doxycycline 100mg capsules OD) for 14 days.

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily

Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm

Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets OD + Esomeprazole 20mg tablets BID + Nitazoxanide 500 mg tablets BID +Doxycycline 100mg capsules OD) for 14 days

Group Type ACTIVE_COMPARATOR

Vonoprazan

Intervention Type DRUG

Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily

Interventions

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Vonoprazan

Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily

Intervention Type DRUG

Other Intervention Names

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Clarithromycin Amoxycillin Esomeprazole Levofloxacin Doxycicline Nitazoxanide

Eligibility Criteria

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Inclusion Criteria

* Age above 18 years of both genders.
* Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.
* Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).
* Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).
* Patients signing an informed consent.

Exclusion Criteria

* Patients refusing to sign an informed consent.
* Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .
* Patients who have chronic debilitating and advanced systemic diseases.
* Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.
* Any lactating or pregnant female.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Reda Elwakil

Emeritus Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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111954

Identifier Type: -

Identifier Source: org_study_id

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