Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
Vonoprazan Study In Patients With Erosive Esophagitis to Evaluate Long-term Safety: A Study to Evaluate the Safety of Long-term Administration of Vonoprazan in Maintenance Treatment in Patients With Erosive Esophagitis (EE)
3 other identifiers
interventional
208
1 country
36
Brief Summary
The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in patients receiving maintenance treatment after healed erosive esophagitis (EE), and the curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2016
Longer than P75 for phase_4
36 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, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2016
CompletedStudy Start
First participant enrolled
March 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2022
CompletedResults Posted
Study results publicly available
December 13, 2023
CompletedDecember 13, 2023
December 1, 2023
6 years
February 8, 2016
March 3, 2023
December 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants With Malignant Alteration of Epithelial Cells
Numbers of participants with malignant alteration of epithelial cells for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Time Frame: Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With Parietal Cell Protrusion/Hyperplasia
Numbers of participants with parietal cell protrusion/hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With Foveolar Hyperplasia
Numbers of participants with foveolar hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With Enterochromaffin-like-cell Hyperplasia
Numbers of participants with enterochromaffin-like-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With G-cell Hyperplasia
Numbers of participants with G-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Up to Week 268 (Week 260 in Maintenance Phase)
Secondary Outcomes (19)
Percentage of Participants With Recurrence of Erosive Esophagitis (EE)
Up to Week 268 (Week 260 in Maintenance Phase)
Percentage of Participants Who Healed EE at the End of Healing Phase
Up to Week 8
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase
260 weeks (Baseline, up to the end of Maintenance Phase)
Number of Participants With Fundic Gland Polyp
Up to Week 268 (Week 260 in Maintenance Phase)
Number of Participants With Hyperplastic Polyp
Up to Week 268 (Week 260 in Maintenance Phase)
- +14 more secondary outcomes
Study Arms (2)
Vonoprazan group
EXPERIMENTALVonoprazan 20 mg administered orally once daily in the healing phase + vonoprazan 10 mg (as the initial dose and adjusted to vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase
Lansoprazole group
ACTIVE COMPARATORLansoprazole 30 mg administered orally once daily in the healing phase + lansoprazole 15 mg (as the initial dose and adjusted to lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase
Interventions
Eligibility Criteria
You may qualify if:
- Healing Phase:
- Participants endoscopically diagnosed with EE of grades A to D by the LA Classification Grading System at the start of treatment (Week 0 of the healing phase)
- Participants with H. pylori negative
- Participants who, in the opinion of the principal investigator or investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
- Participants who can sign and date an informed consent form and information sheet prior to the conduction of the clinical research procedures.
- Male or female participants aged 20 years or older at the time of informed consent
- Therapeutic category: Ambulatory
- Maintenance Phase:
- Participants who have endoscopically confirmed EE healing\* (mucous membrane disorder is not observed) at completion of the healing phase (Week 4 or 8 of the healing phase)
- \* Participants who are classified as grade 0 according to severity classification of EE (See Table 9.b)
- Participants who have been determined to be appropriate as subjects for maintenance treatment of EE by the principal investigator or investigator
You may not qualify if:
- Healing Phase:
- Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison syndrome
- Participants who received treatment with PPIs (including vonoprazan) within 4 weeks (Week -4 to Week 0) prior to the start of healing phase (Week 0 of the healing phase)
- Participants with a history of H. pylori eradication.
- Participants who have received surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis \[excluding Schatzki's ring\], etc.)
- Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
- Participants with clinically apparent hepatic impairment (e.g., AST or ALT levels at the time of informed consent: \>1.5 times the upper limit of normal (ULN).
- Participants with renal impairment or renal failure \[creatinine clearance (CCr) ˂30 mL/min, etc.\]
- Participants with a history of hypersensitivity or allergy for PPIs.
- Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy
- Participants with a malignant tumor
- Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant
- Participants with one of the diseases listed under administration contraindication in the vonoprazan or lansoprazole package insert
- Participants planning to take prohibited concomitant medications during the research period
- Participants participating in other clinical studies
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (36)
Tokatsu Tsujinaka Hospital
Abiko, Chiba, Japan
Hohnodai Hospital National Center For Global Health and Medicine
Ichikawa, Chiba, Japan
Red Cross Matsuyama Hospital
Matsuyama, Ehime, Japan
Kawakubo Clinic
Kama, Fukuoka, Japan
Hakodate Hospital
Hakodate, Hokkaido, Japan
Aoyama Medical Clinic
Kobe, Hyōgo, Japan
Hyogo College Of Medicine
Nishinomiya, Hyōgo, Japan
KKR Takamatsu Hospital
Takamatsu, Kagawa-ken, Japan
Shirane Clinic
Sendai, Miyagi, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Shin-Beppu Hospital
Beppu, Oita Prefecture, Japan
Kawasaki Medical University
Kurashiki, Okayama-ken, Japan
Shiga Hospital
Ōtsu, Shiga, Japan
Shiga University Of Medical Science Hospital
Ōtsu, Shiga, Japan
Shimane University Hospital
Izumo, Shimane, Japan
Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka, Japan
Kohga Hospital
Yaizu, Shizuoka, Japan
Masuyama Clinic
Ōtawara, Tochigi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Banno Clinic
Ōta-ku, Tokyo, Japan
Shimokitazawa Tomo Clinic
Setagaya-ku, Tokyo, Japan
National Center For Global Health and Medicine
Shinjyuku-ku, Tokyo, Japan
Nippon Medical School Hospital
Shinjyuku-ku, Tokyo, Japan
Chihaya Hospital
Fukuoka, Japan
Harada Hospital
Fukuoka, Japan
Kimura Shiro Clinic
Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Japan
Mori Clinic
Fukuoka, Japan
Hanabata Clinic
Kumamoto, Japan
Morinaga Ueno Clinic
Kumamoto, Japan
Oki Hospital
Kyoto, Japan
Asahigaoka Hospital
Okayama, Japan
Kawasaki Hospital
Okayama, Japan
Arita Hospital
Ōita, Japan
Matsuki Clinic
Shizuoka, Japan
Oizumi Medical Clinic
Yamagata, Japan
Related Publications (1)
Uemura N, Kinoshita Y, Haruma K, Kushima R, Yao T, Akiyama J, Aoyama N, Baba Y, Suzuki C, Ishiguro K. Vonoprazan as a Long-term Maintenance Treatment for Erosive Esophagitis: VISION, a 5-Year, Randomized, Open-label Study. Clin Gastroenterol Hepatol. 2025 Apr;23(5):748-757.e5. doi: 10.1016/j.cgh.2024.08.004. Epub 2024 Aug 27.
PMID: 39209187DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2016
First Posted
February 10, 2016
Study Start
March 20, 2016
Primary Completion
March 5, 2022
Study Completion
March 5, 2022
Last Updated
December 13, 2023
Results First Posted
December 13, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.