Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20 mg Compared to Lansoprazole 30 mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Duodenal Ulcer Subjects With or Without Helicobacter Pylori Infection
3 other identifiers
interventional
533
4 countries
81
Brief Summary
The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2017
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedStudy Start
First participant enrolled
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2019
CompletedResults Posted
Study results publicly available
June 12, 2020
CompletedJune 12, 2020
May 1, 2020
2 years
February 8, 2017
May 27, 2020
May 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers
Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.
Week 4 or Week 6
Secondary Outcomes (3)
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment
4 weeks post treatment (Up to 10 weeks)
Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4
Week 4
Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
Week 2 up to Week 6
Study Arms (2)
TAK-438 20 mg
EXPERIMENTALH. pylori negative (HP -) participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. H. pylori positive (HP +) participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
Lansoprazole 30 mg
EXPERIMENTALH. pylori negative (HP -) participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
Interventions
1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).
Eligibility Criteria
You may qualify if:
- \. Has endoscopic evidence of active duodenal ulcer(s) (i.e., mucosal defects with white coating \[including cases associated with blood coagulation as long as there is no active bleeding\]) measuring 5 mm or larger in longest diameter within 14 days prior to randomization.
You may not qualify if:
- Has received TAK-438 in a previous clinical study or as a therapeutic agent.
- Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
- Has been treated with Helicobacter pylori eradication therapy within 30 days prior to study treatment.
- Has a diagnosis of duodenal malignancy or a duodenal ulcer whose morphology suggested malignancy as evident by endoscopy within 14 days prior to randomization.
- Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by endoscopy within 14 days prior to randomization.
- Has a linear ulcer (including a linear ulcer scar) that has been confirmed as evident by endoscopy within 14 days prior to randomization.
- Has active postoperative (eg, endoscopic mucosal resection / endoscopic submucosal dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization.
- Has gastric ulcer that has been confirmed by endoscopy within 14 days prior to randomization.
- Has ulcers for which medical therapy alone is not indicated (eg, perforation, pyloric stenosis, duodenal stenosis, major bleeding).
- Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (eg, endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1.
- Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
- Has undergone major surgical procedures within 30 days prior to Visit 1 or are scheduled to undergo surgical procedures that may affect gastric acid secretion (eg, abdominal surgery, vagotomy or craniotomy).
- Has a history of malignancy or was treated for malignancy within 5 years before the start of the visit 1 (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
- Has a known acquired immunodeficiency syndrome (AIDS) or hepatitis infection, including hepatitis virus carriers (hepatitis B surface-antigen \[HBsAg\] - or hepatitis C virus (HCV)-antibody-positive) (the participant may be included in the study if he/she is HCV-viral load-RNA-negative).
- Laboratory tests performed prior to randomization revealed any of the following abnormalities in the participant:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (81)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230024, China
Yijishan hospital of Wan nan Medical college
Wuhu, Anhui, 241001, China
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
The General Hospital of People's Armed Police Forces China
Beijing, Beijing Municipality, 100039, China
The Central Hospital of China Aerospace Corporation
Beijing, Beijing Municipality, 100049, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Tong Ren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
Peking University First Hospital
Beijing,P.R., Beijing Municipality, 100034, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 40010, China
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
Fuzhou, Fujian, 350025, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhangzhou Hospital
Zhangzhou, Fujian, 363000, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510655, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Haikou People's Hospital
Haikou, Hainan, 570208, China
Shiyan Taihe Hospital
Shiyan, Hebei, 442000, China
The 2nd Xiangya Hospital Central South University
Changsha, Hu'nan, 410011, China
Chenzhou No.1 People's Hospital
Chenzhou, Hu'nan, 432000, China
Changsha Central Hospital
Yuhua, Hu'nan, 410018, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
Union Hospital of Tongji Medical College of Huazhong Science and Techology University
Wuhan, Hubei, 420104, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Wuhan General Hospital of Guangzhou Military
Wuhan, Hubei, 430070, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
Wuxi 4th People's Hospital
Wuxi, Jiangsu, 214062, China
Wuxi People's Hospital
Wuxi, Jiangsu, 241023, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006, China
Jiangxi Nanchang 3rd Hospital
Nanchang, Jiangxi, 330009, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
Jilin 4th People'S hospital
Changchun, Jilin, 130012, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
Jilin central Hospital
Jilin, Jilin, 132011, China
Jilin Siping Central Hospital
Siping, Jilin, 136000, China
General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110016, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia Hui, 750004, China
People's Hospital of Qinghai Province
Xining, Qinghai, 810007, China
The 2nd Hospital of Xi An Jiaotong University
Xi'an, Shan'xi, 710004, China
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
Huangpu Qu, Shanghai Municipality, 200020, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200442, China
Tianjin Medical University Affiliated General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yun'nan, 650032, China
1st Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310013, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310016, China
The Second Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Cebu Doctors University Hospital
Cebu City, 6000, Philippines
St. Luke's Medical Center Global City
City of Taguig, 1634, Philippines
De La Salle University Medical Center
Dasmarinas City, Cavite, 4114, Philippines
Davao Doctors Hospital
Davao City, 8000, Philippines
West Visayas State University Medical Center
Iloilo City, 5000, Philippines
Philippine General Hospital
Manila, 1000, Philippines
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
The Catholic University of Korea, Bucheon St. Mary s Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Hanyang Univerisy Guri Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Wonkwang University Hospital
Iksan-si, Jeollabuk-do, 54538, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Related Publications (1)
Hou X, Wang J, Du Q, Tian D, Hu N, Liu D, Zhou F, Xie L, Gu L, Kudou K, Zhang S. Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials. Biol Pharm Bull. 2024;47(8):1405-1414. doi: 10.1248/bpb.b24-00011.
PMID: 39085080DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2017
First Posted
February 10, 2017
Study Start
April 5, 2017
Primary Completion
March 19, 2019
Study Completion
July 19, 2019
Last Updated
June 12, 2020
Results First Posted
June 12, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.