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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

Primary Purpose

Helicobacter Pylori

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Vonoprazan
Amoxicillin
Clarithromycin
Bismuth Potassium citrate
Esomeprazole
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

  1. 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.
  2. Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
  3. 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).
  4. 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).

Sites / Locations

  • Friendship Hospital, Capital Medical University
  • Peking University Third Hospital
  • Fuzhou General Hospital of Nanjing Military Command
  • The First Affiliated Hospital of Xiamen University
  • Zhongshan Hospital Xiamen University
  • The First People's Hospital of Foshan
  • Guangzhou First People's Hospital
  • Haikou people's Hosptial
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Renmin Hospital of Wuhan University
  • Xiangya Hospital of Central South University, Digestive Department
  • The Second Xiangya Hospital of Central South University
  • The Third Xiangya Hospital of Central South University
  • The First People's Hospital of Changzhou
  • Nanjing Drum Tower Hospital
  • Jiangsu Province Hospital
  • Nanjing First Hospital
  • Yangzhou First People's Hospital
  • Northern Jiangsu People's Hospital
  • The Third Hospital of Nanchang
  • The First Affiliated Hospital of Nanchang University Digestive Department
  • Shengjing Hospital of China Medical University
  • General Hospital of Ningxia Medical University
  • Shanghai East Hospital
  • Zhongshan Hospital, Fudan University
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • First Affiliated Hospital of Xinjiang Medical University
  • The Second Affiliated Hospital, Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vonoprazan 20 mg

Esomeprazole 20 mg

Arm Description

Vonoprazan 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.

Esomeprazole 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2019
Last Updated
October 26, 2022
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT04198363
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vonoprazan 20 mg
Arm Type
Experimental
Arm Description
Vonoprazan 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.
Arm Title
Esomeprazole 20 mg
Arm Type
Active Comparator
Arm Description
Esomeprazole 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.
Intervention Type
Drug
Intervention Name(s)
Vonoprazan
Other Intervention Name(s)
TAK-438
Intervention Description
Vonoprazan Tablets
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Amoxicillin Capsules
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
Clarithromycin Tablets
Intervention Type
Drug
Intervention Name(s)
Bismuth Potassium citrate
Intervention Description
Bismuth Potassium citrate
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Esomeprazole Tablets
Primary Outcome Measure Information:
Title
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment
Description
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.
Time Frame
Week 4 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Fuzhou General Hospital of Nanjing Military Command
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
The First People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Haikou people's Hosptial
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570208
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Xiangya Hospital of Central South University, Digestive Department
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Yangzhou First People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
The Third Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University Digestive Department
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

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

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