Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
A Randomized, Double-Blind, Double-Dummy Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Compared to Lansoprazole 30 mg in the Treatment of Subjects With Erosive Esophagitis
3 other identifiers
interventional
481
4 countries
64
Brief Summary
The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2015
64 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
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2017
CompletedResults Posted
Study results publicly available
June 3, 2019
CompletedJune 3, 2019
February 1, 2019
2.3 years
March 9, 2015
July 24, 2018
February 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.
8 weeks
Secondary Outcomes (8)
Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment
Week 2 and Week 4
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 weeks)
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)
Number of Participants With Markedly Abnormal Vital Sign Measurements
From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)
- +3 more secondary outcomes
Study Arms (2)
Vonoprazan 20 mg
EXPERIMENTALVonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
Lansoprazole 30 mg
ACTIVE COMPARATORLansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
Interventions
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 in an endoscopy to have erosive esophagitis, ie, the Los Angeles (LA) classification grades A to D within 7 days of the start of the Day 1 (Visit 2).
- Note: The recruitment goal is to ensure that those with LA classification grade C/D will account for more than 30% of all participants enrolled (144/480), with no further recruitment of those with grade A/B considered when they account for more than 70% (336/480) of all participants.
- 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 admitted temporarily 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.
You may not qualify if:
- Has received any investigational compound within 84 days prior to the start of the Observation phase.
- Has received TAK-438 in a previous clinical study or as a therapeutic agent.
- Is an immediate family member, study site employee, or is in a dependant 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 serious central nerve system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease.
- Has a history of hypersensitivity or allergies to TAK-438 (including its excipients\*) or to proton pump inhibitors (PPIs).
- \*D-mannitol, crystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, yellow iron sesquioxide and iron sesquioxide.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Observation Phase (Visit 1).
- 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 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 Observation 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).
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (64)
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
China-Japan Friendship hospital
Beijing, Beijing Municipality, 100029, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Beijing Tongren Hospital, Capital Medical Univeristy
Beijing, Beijing Municipality, 100370, China
PLA.The Military General Hospital of Beijing
Beijing, Beijing Municipality, 100700, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350100, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
The 2nd Xiangya Hospital Central South University
Changsha, Hu'nan, 410011, China
Chenzhou No.1 People's Hospital
Chenzhou, Hu'nan, 432000, 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
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Jiangsu Province People's Hospital
Nanjing, Jiangsu, 210029, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041, China
Jilin central Hospital
Jilin, Jilin, 132011, 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
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
Unknown Facility
Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 0, 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
Tianjin, 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
Cheng Ching General Hospital-Chung Kang Branch
Taichung, 407, 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, 114, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Related Publications (1)
Xiao Y, Zhang S, Dai N, Fei G, Goh KL, Chun HJ, Sheu BS, Chong CF, Funao N, Zhou W, Chen M. Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis. Gut. 2020 Feb;69(2):224-230. doi: 10.1136/gutjnl-2019-318365. Epub 2019 Aug 13.
PMID: 31409606DERIVED
MeSH Terms
Interventions
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
March 9, 2015
First Posted
March 17, 2015
Study Start
March 24, 2015
Primary Completion
July 27, 2017
Study Completion
July 27, 2017
Last Updated
June 3, 2019
Results First Posted
June 3, 2019
Record last verified: 2019-02