AzTrials
AzTrials

Helicobacter Pylori InfectionPhase 4NCT04901663

Vonoprazan in Helicobacter Pylori Treatment an RCT

A Phase 4 study testing Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG and Vonoprazan 20 MG; Amoxicillin 1000 MG in people with Helicobacter Pylori Infection, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG and Vonoprazan 20 MG; Amoxicillin 1000 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
1 sitePakistan
Study dates
21 Jun 2021to 16 Aug 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Dr Ruth KM Pfau Civil Hospital Karachi

    Karachi, Sindh, 74400

Other trials in Pakistan

About this study

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

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

Read the 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.

Being tested
Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG, Vonoprazan 20 MG; Amoxicillin 1000 MG
Keywords
helicobacter pylori, Vonoprazan, potassium-competitive acid inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MGDrug

    Also called Omeprazole Group

    Orally twice daily for 2 weeks

  • Vonoprazan 20 MG; Amoxicillin 1000 MGDrug

    Also called Vonoprazan Group

    Orally twice daily for 2 weeks

Study groups in NCT04901663
Study groupRoleWhat they receive
Omeprazole GroupActive comparatorOmeprazole 20 mg BD Amoxicillin 1000 mg BD Clarithromycin 500 mg BD
Receives: Drug: Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG
Vonoprazan GroupExperimentalVonoprazan 20 mg BD Amoxicillin 1000 mg BD
Receives: Drug: Vonoprazan 20 MG; Amoxicillin 1000 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Helicobacter Pylori Eradication

    Stool Heliobacter Pylori Antigen = Negative

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start21 Jun 2021
  3. Primary completion13 Aug 2021
  4. Study completion16 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Control Trial
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04901663
Sponsor's protocol ID
BAD-VPZ-001
Status last verified
Aug 2021
First submitted
18 May 2021
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31024299

  • 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.

    PubMed 28456631

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

    PubMed 28891138

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

    PubMed 30893536

  • 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.

    PubMed 30180998

  • 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.

    PubMed 33089598

  • 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.

    PubMed 32545856

  • 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.

    PubMed 26935876

  • 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.

    PubMed 27867688

  • 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.

    PubMed 29138921

  • 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.

    PubMed 31111585

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG and Vonoprazan 20 MG; Amoxicillin 1000 MG in people with Helicobacter Pylori Infection, run by Dow University of Health Sciences at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Helicobacter Pylori Eradication (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04901663, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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