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Helicobacter PyloriPhase 3NCT04198363

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

A Phase 3 study testing Vonoprazan, Amoxicillin and Clarithromycin in people with Helicobacter Pylori, run by Takeda at 29 sites in China.

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

The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Helicobacter Pylori
What is being tested?
Vonoprazan, Amoxicillin and Clarithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
510 participants
Where
29 sitesChina
Study dates
30 Apr 2020to 25 Nov 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Helicobacter pylori (HP)-positive participants as determined by ^13C-urea breath test (^13C-UBT) at the start of the study (Visit 1 [screening]) and who require HP eradication in Physician judgment.

Who cannot join

  • Participant had any of the following conditions at the start of the study (Visit 1, screening): acute upper gastrointestinal bleeding, active gastric ulcer (GU) or duodenal ulcer (DU) characterized by defective mucos with white coating (with or without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML). However, participants with gastritis, gastric or duodenal erosion are permitted to participate.
  • Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
  • Participant has a history of malignancy or was treated for malignancy within 5 years before the start of the screening visit (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
  • Participant has a known acquired immunodeficiency syndrome or hepatitis infection, including hepatitis virus carriers (hepatitis B surface antigen [HBsAg] or hepatitis C virus [HCV]- antibody-positive).

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Xiangya Hospital of Central South University, Digestive Department

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

  • Fuzhou General Hospital of Nanjing Military Command

    Fuzhou, Fujian, 350000

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • Haikou people's Hosptial

    Haikou, Hainan, 570208

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330000

  • The First Affiliated Hospital of Nanchang University Digestive Department

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210029

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200000

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361004

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • Yangzhou First People's Hospital

    Yangzhou, Jiangsu, 225000

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

Other trials in China

About this study

Official title: A Randomized Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral TAK-438 20 mg Compared to Esomeprazole 20 mg Twice Daily in Subjects With Helicobacter Pylori Infection

The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.

Read the detailed description

The drug being tested in this study is called vonoprazan (TAK-438). Vonoprazan is being tested to treat people who have helicobacter pylori infection.

The study is planned to enroll 425 patients at the beginning and will enroll a maximum of approximately 510 patients based on the interim analysis results. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

Vonoprazan 20 mg

Esomeprazole 20 mg

All participants will be asked to take one tablet in combination with bismuth containing quadruple therapy (amoxicillin, clarithromycin and bismuth potassium citrate) twice at the same time each day throughout the study.

This multi-center trial will be conducted in China. The overall time to participate in this study is 10 weeks. Participants will make multiple visits to the clinic, and 28 days after last dose of study drug for a follow-up assessment.

Being tested
Vonoprazan, Amoxicillin, Clarithromycin, Bismuth Potassium citrate, Esomeprazole
Keywords
Drug Therapy

What participants receive

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

  • VonoprazanDrug

    Also called TAK-438

    Vonoprazan Tablets

  • AmoxicillinDrug

    Amoxicillin Capsules

  • ClarithromycinDrug

    Clarithromycin Tablets

  • Bismuth Potassium citrateDrug

    Bismuth Potassium citrate

  • EsomeprazoleDrug

    Esomeprazole Tablets

Study groups in NCT04198363
Study groupRoleWhat they receive
Vonoprazan 20 mgExperimentalVonoprazan 20 mg, tablets, orally, twice daily given in combination with bismuth containing quadruple therapy (amoxicillin 1 gm, capsules, clarithromycin 500 mg, tablets, and bismuth potassium citrate 600 mg) orally, twice daily for up to 2 weeks.
Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Bismuth Potassium citrate
Esomeprazole 20 mgActive comparatorEsomeprazole 20 mg, tablets, orally, twice daily given in combination with bismuth containing quadruple therapy (amoxicillin 1 gm, capsules, clarithromycin 500 mg, tablets, and bismuth potassium citrate 600 mg) orally, twice daily for up to 2 weeks.
Receives: Drug: Amoxicillin; Drug: Clarithromycin; Drug: Bismuth Potassium citrate; Drug: Esomeprazole

What is being measured

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

  1. Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment

    HP infection status was determined by ^13C Urea Breath Test (^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The percentages are rounded off to report the nearest ten.

    Measured: Week 4 post-treatment

Timeline

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

  1. First posted13 Dec 2019
  2. Study start30 Apr 2020
  3. Primary completion1 Nov 2021
  4. Study completion25 Nov 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04198363
Sponsor's protocol ID
Vonoprazan-3002
Status last verified
Oct 2022
First submitted
12 Dec 2019
Last updated
7 Sep 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Song Z, Du Q, Zhang G, Zhang Z, Liu F, Lu N, Gu L, Kuroda S, Zhou L. Vonoprazan-based quadruple therapy is non-inferior to esomeprazole-based quadruple therapy for Helicobacter pylori eradication: A multicenter, double-blind, randomized, phase 3 study. Chin Med J (Engl). 2025 Nov 20;138(22):2938-2946. doi: 10.1097/CM9.0000000000003437. Epub 2025 Feb 18.

    PubMed 39965795

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vonoprazan, Amoxicillin and Clarithromycin in people with Helicobacter Pylori, run by Takeda at 29 sites in China.

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 1 inclusion and 4 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment (time frame: Week 4 post-treatment). 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 NCT04198363, which also lists 1 linked publication.

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 7 Sep 2023.

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