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

PHASE3CompletedINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

April 30, 2020

Primary Completion Date

November 1, 2021

Study Completion Date

November 25, 2021

Conditions
Helicobacter Pylori
Interventions
DRUG

Vonoprazan

Vonoprazan Tablets

DRUG

Amoxicillin

Amoxicillin Capsules

DRUG

Clarithromycin

Clarithromycin Tablets

DRUG

Bismuth Potassium citrate

Bismuth Potassium citrate

DRUG

Esomeprazole

Esomeprazole Tablets

Trial Locations (29)

100000

Friendship Hospital, Capital Medical University, Beijing

Peking University Third Hospital, Beijing

110004

Shengjing Hospital of China Medical University, Shenyang

200000

Shanghai East Hospital, Shanghai

Zhongshan Hospital, Fudan University, Shanghai

200025

Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

210029

Jiangsu Province Hospital, Nanjing

Nanjing First Hospital, Nanjing

213003

The First People's Hospital of Changzhou, Changzhou

225000

Yangzhou First People's Hospital, Yangzhou

225001

Northern Jiangsu People's Hospital, Yangzhou

310000

The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

330000

The Third Hospital of Nanchang, Nanchang

330006

The First Affiliated Hospital of Nanchang University Digestive Department, Nanchang

350000

Fuzhou General Hospital of Nanjing Military Command, Fuzhou

361004

The First Affiliated Hospital of Xiamen University, Xiamen

Zhongshan Hospital Xiamen University, Xiamen

410008

Xiangya Hospital of Central South University, Digestive Department, Changsha

410011

The Second Xiangya Hospital of Central South University, Changsha

410013

The Third Xiangya Hospital of Central South University, Changsha

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

430060

Renmin Hospital of Wuhan University, Wuhan

510180

Guangzhou First People's Hospital, Guangzhou

528000

The First People's Hospital of Foshan, Foshan

570208

Haikou people's Hosptial, Haikou

710004

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an

750004

General Hospital of Ningxia Medical University, Yinchuan

830054

First Affiliated Hospital of Xinjiang Medical University, Ürümqi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY