Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

NCT06101420 | Completed Phase 3

• 1 other identifier: 111954
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Helicobacter Pylori Eradication

Keywords

P-CABs; Vonoprazan; H.pylori eradication

Outcome Measures

Primary Outcomes (1)

• H.pylori eradication

  The rate of the patients who achieved H.pylori eradication as measured by negative H.Pylori stool antigen test in the four arms of the study was reported.

  six weeks

Secondary Outcomes (1)

• Safety of Vonoprazan use

  six weeks

Study Arms (4)

Arm 1 Vonoprazn Triple Therapy Arm

EXPERIMENTAL

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

Drug: Vonoprazan

Arm 2 Proton Pump Inhibitor Triple Therapy Arm

ACTIVE COMPARATOR

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

Drug: Vonoprazan

Arm 3 Vonoprazan Quadruple Therapy Arm

EXPERIMENTAL

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.

Drug: Vonoprazan

Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm

ACTIVE COMPARATOR

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

Drug: Vonoprazan

Interventions

Vonoprazan 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

Also known as: Clarithromycin, Amoxycillin, Esomeprazole, Levofloxacin, Doxycicline, Nitazoxanide

Arm 1 Vonoprazn Triple Therapy Arm; Arm 2 Proton Pump Inhibitor Triple Therapy Arm; Arm 3 Vonoprazan Quadruple Therapy Arm; Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients refusing to sign an informed consent.
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, 11341, Egypt

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Clarithromycin; Amoxicillin; Esomeprazole; Levofloxacin; nitazoxanide

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)