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

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT04198363

Collaborator

(none)

510

Enrollment

Locations

Arms

18.9

Actual Duration (Months)

17.6

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Drug: Vonoprazan Drug: Amoxicillin Drug: Clarithromycin Drug: Bismuth Potassium citrate Drug: Esomeprazole	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

510 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 30, 2020

Actual Primary Completion Date :

Nov 1, 2021

Actual Study Completion Date :

Nov 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vonoprazan 20 mg 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.	Drug: Vonoprazan Vonoprazan Tablets Other Names: TAK-438 Drug: Amoxicillin Amoxicillin Capsules Drug: Clarithromycin Clarithromycin Tablets Drug: Bismuth Potassium citrate Bismuth Potassium citrate
Active Comparator: Esomeprazole 20 mg 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.	Drug: Amoxicillin Amoxicillin Capsules Drug: Clarithromycin Clarithromycin Tablets Drug: Bismuth Potassium citrate Bismuth Potassium citrate Drug: Esomeprazole Esomeprazole Tablets

Arm

Intervention/Treatment

Experimental: Vonoprazan 20 mg

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.

Drug: Vonoprazan

Vonoprazan Tablets

Other Names:

TAK-438

Drug: Amoxicillin

Amoxicillin Capsules

Drug: Clarithromycin

Clarithromycin Tablets

Drug: Bismuth Potassium citrate

Bismuth Potassium citrate

Active Comparator: Esomeprazole 20 mg

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.

Drug: Amoxicillin

Amoxicillin Capsules

Drug: Clarithromycin

Clarithromycin Tablets

Drug: Bismuth Potassium citrate

Bismuth Potassium citrate

Drug: Esomeprazole

Esomeprazole Tablets

Outcome Measures

Primary Outcome Measures

Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment [Week 4 post-treatment]
HP infection status will be 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Friendship Hospital, Capital Medical University	Beijing	Beijing	China	100000
2	Peking University Third Hospital	Beijing	Beijing	China	100000
3	Fuzhou General Hospital of Nanjing Military Command	Fuzhou	Fujian	China	350000
4	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China	361004
5	Zhongshan Hospital Xiamen University	Xiamen	Fujian	China	361004
6	The First People's Hospital of Foshan	Foshan	Guangdong	China	528000
7	Guangzhou First People's Hospital	Guangzhou	Guangdong	China	510180
8	Haikou people's Hosptial	Haikou	Hainan	China	570208
9	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
10	Renmin Hospital of Wuhan University	Wuhan	Hubei	China	430060
11	Xiangya Hospital of Central South University, Digestive Department	Changsha	Hunan	China	410008
12	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410011
13	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China	410013
14	The First People's Hospital of Changzhou	Changzhou	Jiangsu	China	213003
15	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China	210008
16	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029
17	Nanjing First Hospital	Nanjing	Jiangsu	China	210029
18	Yangzhou First People's Hospital	Yangzhou	Jiangsu	China	225000
19	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	China	225001
20	The Third Hospital of Nanchang	Nanchang	Jiangxi	China	330000
21	The First Affiliated Hospital of Nanchang University Digestive Department	Nanchang	Jiangxi	China	330006
22	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110004
23	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	750004
24	Shanghai East Hospital	Shanghai	Shanghai	China	200000
25	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200000
26	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200025
27	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China	710004
28	First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China	830054
29	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310000