NCT04901663

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

May 18, 2021

Last Update Submit

August 17, 2021

Conditions

Helicobacter Pylori Infection

Keywords

helicobacter pyloriVonoprazanpotassium-competitive acid inhibitor

Outcome Measures

Primary Outcomes (1)

  • Helicobacter Pylori Eradication

    Stool Heliobacter Pylori Antigen = Negative

    4 weeks

Study Arms (2)

Omeprazole Group

ACTIVE COMPARATOR

Omeprazole 20 mg BD Amoxicillin 1000 mg BD Clarithromycin 500 mg BD

Drug: Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG

Vonoprazan Group

EXPERIMENTAL

Vonoprazan 20 mg BD Amoxicillin 1000 mg BD

Drug: Vonoprazan 20 MG; Amoxicillin 1000 MG

Interventions

Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MGDRUG

Orally twice daily for 2 weeks

Also known as: Omeprazole Group
Omeprazole Group
Vonoprazan 20 MG; Amoxicillin 1000 MGDRUG

Orally twice daily for 2 weeks

Also known as: Vonoprazan Group
Vonoprazan Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Helicobacter Pylori Positive by any one of following:
  • Histopathology by Giemsa Stain Stool Antigen

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Ruth KM Pfau Civil Hospital Karachi

Karachi, Sindh, 74400, Pakistan

Location

Related Publications (11)

  • Abadi ATB, Ierardi E. Vonoprazan and Helicobacter pylori Treatment: A Lesson From Japan or a Limited Geographic Phenomenon? Front Pharmacol. 2019 Apr 5;10:316. doi: 10.3389/fphar.2019.00316. eCollection 2019.

    PMID: 31024299RESULT

  • Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.

    PMID: 28456631RESULT

  • Burucoa C, Axon A. Epidemiology of Helicobacter pylori infection. Helicobacter. 2017 Sep;22 Suppl 1. doi: 10.1111/hel.12403.

    PMID: 28891138RESULT

  • Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.

    PMID: 30893536RESULT

  • Munoz N, Sanchez-Delgado J, Baylina M, Lopez-Gongora S, Calvet X. Prevalence of Helicobacter pylori resistance after failure of first-line therapy. A systematic review. Gastroenterol Hepatol. 2018 Dec;41(10):654-662. doi: 10.1016/j.gastrohep.2018.06.014. Epub 2018 Sep 1. English, Spanish.

    PMID: 30180998RESULT

  • Ke H, Li J, Lu B, Yang C, Wang J, Wang Z, Liu L, Chen Y. The appropriate cutoff gastric pH value for Helicobacter pylori eradication with bismuth-based quadruple therapy. Helicobacter. 2021 Feb;26(1):e12768. doi: 10.1111/hel.12768. Epub 2020 Oct 21.

    PMID: 33089598RESULT

  • Wang YC, Chen YP, Ho CY, Liu TW, Chu CH, Wang HY, Liou TC. The Impact of Gastric Juice pH on the Intraluminal Therapy for Helicobacter pylori Infection. J Clin Med. 2020 Jun 14;9(6):1852. doi: 10.3390/jcm9061852.

    PMID: 32545856RESULT

  • Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.

    PMID: 26935876RESULT

  • Yamada S, Kawakami T, Nakatsugawa Y, Suzuki T, Fujii H, Tomatsuri N, Nakamura H, Sato H, Okuyama Y, Kimura H, Yoshida N. Usefulness of vonoprazan, a potassium ion-competitive acid blocker, for primary eradication of Helicobacter pylori. World J Gastrointest Pharmacol Ther. 2016 Nov 6;7(4):550-555. doi: 10.4292/wjgpt.v7.i4.550.

    PMID: 27867688RESULT

  • Suzuki H, Mori H. World trends for H. pylori eradication therapy and gastric cancer prevention strategy by H. pylori test-and-treat. J Gastroenterol. 2018 Mar;53(3):354-361. doi: 10.1007/s00535-017-1407-1. Epub 2017 Nov 14.

    PMID: 29138921RESULT

  • Kato M, Ota H, Okuda M, Kikuchi S, Satoh K, Shimoyama T, Suzuki H, Handa O, Furuta T, Mabe K, Murakami K, Sugiyama T, Uemura N, Takahashi S. Guidelines for the management of Helicobacter pylori infection in Japan: 2016 Revised Edition. Helicobacter. 2019 Aug;24(4):e12597. doi: 10.1111/hel.12597. Epub 2019 May 20.

    PMID: 31111585RESULT

MeSH Terms

Interventions

OmeprazoleCapsulesClarithromycinAmoxicillin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDosage FormsPharmaceutical PreparationsErythromycinMacrolidesPolyketidesLactonesAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmides

Study Officials

  • Bader F Zuberi, FCPS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 25, 2021

Study Start

June 21, 2021

Primary Completion

August 13, 2021

Study Completion

August 16, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)