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
Phase: PHASE3
Conditions: Helicobacter Pylori
Sponsor: Takeda

CLINICAL STUDY PROTOCOL 
NCT Number: 
Study Title: 
Study Number: 
NCT04198363 
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 
Vonoprazan-3002
Protocol Version and Date: 
Version 03: 20-October-2020 

 
 
TAKEDA PHARMACEUTICALS
PROTOCOL
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
Sponsor:
Takeda Development Center Asia Pte Ltd.
21 Biopolis Road
Nucleos North Tower, Level 4
Singapore 138567
Study Number:
Vonoprazan-3002
IND Number:
Not Applicable
EudraCT Number:
Not Applicable
Compound:
TAK-438/vonoprazan
Date:
20 October 2020
Version/Amendment 
Number:
03
Amendment History: 
Date
Amendment Number
Amendment Type
Region
20 October 2020
03
Nonsubstantial
China
06 May 2020
02
Nonsubstantial
China
28 March 2019
01
Nonsubstantial
China
02 October 2018
Initial protocol
China
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Vonoprazan
Study No. Vonoprazan-3002
Page 2 of 68
Protocol Incorporating Amendment No. 03
20 October 2020
1.0
ADMINISTRATIVE INFORMATION
1.1
Contacts
A separate contact information list will be provided to each site.
Takeda Development Center, Asia Pte Ltd., (TDC Asia) sponsored investigators per individual 
country requirements will be provided with emergency medical contact information cards to be 
carried by each subject.
General advice on protocol procedures should be obtained through the monitor assigned to the 
study site. Information on service providers is given in Section 3.1 and relevant guidelines 
provided to the site.
Contact Type/Role
Contact
Serious adverse event and pregnancy reporting
PRA PVS Clinical Operations:
Email: MHGSafety@prahs.com
Fax: +44 1792 525720
Medical Monitor (medical advice on
protocol and study drug)
Medical Director, Clinical Science
Responsible Medical Officer (carries
overall responsibility for the conduct of 
the study)
Medical Director, Clinical Science
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