Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis
3 other identifiers
interventional
703
4 countries
72
Brief Summary
This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.
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 2015
Typical duration for phase_3
72 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
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
February 21, 2020
CompletedFebruary 21, 2020
February 1, 2020
3.7 years
March 9, 2015
December 13, 2019
February 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase
Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles \[LA\] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference.
24 weeks
Secondary Outcomes (8)
Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase
12 weeks
Number of Participants With Adverse Events (AEs)
From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)
Number of Participants With Abnormal Clinical Laboratory Findings
From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)
Number of Participants With Abnormal Vital Sign Measurements
From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)
- +3 more secondary outcomes
Study Arms (3)
Vonoprazan 10 mg
EXPERIMENTALLansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Vonoprazan 20 mg
EXPERIMENTALLansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing
Lansoprazole 15 mg
ACTIVE COMPARATORLansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Interventions
Lansoprazole capsules or tablets
Vonoprazan placebo-matching tablets
Eligibility Criteria
You may qualify if:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Has been confirmed on endoscopy to have had erosive esophagitis \[Los Angeles (LA) classification grades A to D\] within 84 days of Day 1.
- If the participant is not rolled over from TAK-438\_303 study, he/she has undergone an open-label Proton pump inhibitor (PPI) treatment (Lansoprazole 30 mg, once daily) of 4 or 8 weeks within the TAK-438\_305 protocol.
- Has been confirmed on endoscopy to have healing of erosive esophagitis. This endoscopy, if not part of the TAK-438\_303 study, must have been within the last 14 days prior to randomization, otherwise the endoscopy must be repeated to confirm healing before randomization in the TAK-438\_305 study.
- Is aged 18 years old or older (or the local age of consent if that is older), male or female, at the time of signing an informed consent, and is being treated on an outpatient basis for erosive esophagitis, including those temporarily admitted for examination.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 4 weeks after last dose of study medication.
You may not qualify if:
- Has received any investigational compound (other than study TAK-438\_303) within 84 days prior to screening phase.
- Has received TAK-438 in a previous clinical study (other than study TAK-438\_303) or as a therapeutic agent.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening.
- Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease.
- Has a history of hypersensitivity or allergies to TAK-438 or to proton pump inhibitors (PPIs) including any associated excipients.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the start the screening phase.
- Is required to take excluded medications.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
- Has participated in another clinical study (other than study TAK-438\_303) within the past 30 days from Visit 1.
- Has a history of surgical procedures that may affect the esophagus (eg, fundoplication and mechanical dilatation for esophageal strictures excluding Schatzki's ring) or a history of gastric or duodenal surgery excluding endoscopic removal of benign polyps.
- Has Zollinger-Ellison syndrome or gastric acid hypersecretion or a history of gastric acid hypersecretion.
- Is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
- Has a history of malignancy or was treated for malignancy within 5 years before the start of the Screening Phase (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 acquired immunodeficiency syndrome (AIDS) or hepatitis, 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-antigen or HCV-ribonucleic acid \[RNA\]-negative).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (72)
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
The General Hospital of Peoples Armed Police Forces China
Beijing, Beijing Municipality, 100039, China
Beijing Tongren Hospital, Capital Medical Univeristy
Beijing, Beijing Municipality, 100370, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350100, 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
The 2nd Xiangya Hospital Central South University
Changsha, Hu'nan, 410011, China
Chenzhou No.1 People's Hospital
Chenzhou, Hu'nan, 432000, China
Xiangtan Central Hospital
Xiangtan, Hu'nan, 411100, China
Union Hospital of Tongji Medical College of Huazhong Science and Techology University
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Techology
Wuhan, Hubei, 430030, China
Peoples Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Jiangsu Province People's Hospital
Nanjing, Jiangsu, 210029, China
Yangzhou 1st Hospital
Yangzhou, Jiangsu, 225001, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041, China
China-Japan Union Hospital of Jilin University
Jilin, Jilin, 130033, China
Jilin central Hospital
Jilin, Jilin, 132011, China
Jilin Siping Central Hospital
Siping, Jilin, 136000, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia Hui, 750004, China
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
Shanghai, Shanghai Municipality, 200025, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
TongJi Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
Sixth Peoples Hospital of Shanghai
Shanghai, Shanghai Municipality, 200233, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The 2nd Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
The First Affiated Hospital of Kunming Medical College
Kunming, Yun'nan, 650032, China
2nd Affiliated Hospital, Zhejiang Univ. School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310016, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
PLA.The Military General Hospital of Beijing
Beijing, 100853, China
Unknown Facility
Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 0, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080, China
1st Affiliated Hospital of Zhejiang University
Hangzhou, China
The First Affiliated Hospital of NanChang University
Nanchang, China
The Affiliated DrumTower Hospital of Nanjing University
Nanjing, 210008, China
Unknown Facility
Tianjing, China
Hospital Sultana Bahiyah
Alor Star, Kedah, 5460, Malaysia
Hospital Universiti Sains Malaysia
Kelantan, Kelantan, 16150, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, 88586, Malaysia
Hospital Ampang
Ampang, Selangor, 68000, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, Gyeonggi-do, 03080, South Korea
Kyungpook National University Medical Center
Daegu, Gyeongsangbuk-do, 41404, South Korea
Wonkwang University School Of Medicine & Hospital
Iksan-si, Jeollabuk-do, 54538, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, 06591, South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
E-Da Hospital
Kaohsiung City, 824, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
China Medical University Hospital
Taichung, 333, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 144, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Related Publications (1)
Xiao Y, Qian J, Zhang S, Dai N, Chun HJ, Chiu C, Chong CF, Funao N, Sakurai Y, Eisner JD, Xie L, Chen M. Vonoprazan 10 mg or 20 mg vs. lansoprazole 15 mg as maintenance therapy in Asian patients with healed erosive esophagitis: A randomized controlled trial. Chin Med J (Engl). 2024 Apr 20;137(8):962-971. doi: 10.1097/CM9.0000000000003068. Epub 2024 Mar 29.
PMID: 38654422DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science, MD
Takeda Development Center Asia, Pte Ltd.
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
March 9, 2015
First Posted
March 17, 2015
Study Start
April 1, 2015
Primary Completion
December 24, 2018
Study Completion
December 31, 2018
Last Updated
February 21, 2020
Results First Posted
February 21, 2020
Record last verified: 2020-02
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.