VISION

JRCT ID: jRCTs031180040

Registered date:21/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Erosive Esophagitis
• Date of first enrollment: 06/04/2016
• Target sample size: 195
• Study type: Interventional

Intervention(s)

Participants endoscopically diagnosed with EE of Los Angeles (LA) Classification Grades A to D at the start of treatment (Week 0 of the healing phase) will be randomly assigned to receive either vonoprazan 20 mg or lansoprazole 30 mg to be taken once daily for up to 8 weeks. Subjects with healed EE as confirmed endoscopically at Week 4 or 8 in the healing phase will enter the maintenance phase.
In the maintenance phase, the vonoprazan group and the lansoprazole group will be administered a starting dose of 10 mg and 15 mg, respectively, once daily up to 260 weeks.

Outcome(s)

Primary Outcome

Percentage of participants with clinically significant Gastric mucosa histopathology findings [ Time Frame: Up to Week 268]
For each gastric mucosa histopathological endpoint (presence or absence of malignant alteration of epithelial cells, presence or absence of prominence/hyperplasia of wall cells, presence or absence of hyperplasia of crypt epithelial cells, presence or absence of proliferation of endocrine cells, and presence or absence of hyperplasia of G cells), the proportion of research participants who have the events for assessment in maintenance phase shall be calculated for each treatment group.

Secondary Outcome

1.Endoscopic erosive esophagitis (EE) recurrence rate [ Time Frame: Up to Week 268 ]
2.EE healing rate at the end of the healing phase [ Time Frame: Up to Week 8 ]
3.Number of Participants Reporting One or More Treatment-emergent Adverse Events [ Time Frame: Up to Week 268 ]
4.Percentage of participants with clinically significant endoscopic findings [ Time Frame: Up to Week 268 ]
*For each endoscopic endpoint (presence or absence of fundic gland polyp, presence or absence of hyperplastic polyp, presence or absence of cobblestone mucosa, presence or absence of multiple white flat elevation, and presence or absence of black spots), the proportion of research participants who have the clinically significant events at each time point for assessment shall be calculated for each treatment group.
5.Percentage of participants with clinically significant histological evaluation of gastritis according to the Sydney classification [ Time Frame: Up to Week 268 ]
*For each histological endpoint of gastritis according to the Sydney classification [inflammation (mononuclear infiltration), activity (neutrophilic infiltration), atrophy, intestinal metaplasia, and H. pylori], the proportion of research participants who have the clinically significant events at each time point for assessment shall be calculated for each treatment group.
6.Percentage of participants who have gastric polyp in maintenance phase [ Time Frame: Up to Week 268 ]
*For gastric polyp, the proportion of research participants who have gastric polyp in maintenance phase of this study shall be calculated for each treatment group.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

<Healing Phase>
1.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)
2.Participants with H. pylori negative
3.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.
4.Participants who can sign and date an informed consent form and information sheet prior to the conduction of the clinical research procedures.
5.Male or female participants aged 20 years or older at the time of informed consent
6.Therapeutic category: Ambulatory

<Maintenance Phase>
7.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

8.Participants who have been determined to be appropriate as subjects for maintenance treatment of EE by the principal investigator or investigator

Exclude criteria

<Healing Phase>
1.Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison syndrome
2.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)
3.Participants with a history of H. pylori eradication.
4.Participants who have received surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis [excluding Schatzki's ring], etc.)
5.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.
6.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).
7.Participants with renal impairment or renal failure [creatinine clearance (CCr) <30 mL/min, etc.]
8.Participants with a history of hypersensitivity or allergy for PPIs.
9.Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy
10.Participants with a malignant tumor
11.Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant
12.Participants with one of the diseases listed under administration contraindication in the vonoprazan or lansoprazole package insert
13.Participants planning to take prohibited concomitant medications during the research period
14.Participants participating in other clinical studies
15.Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator

<Maintenance Phase>
16.Participants who have taken PPIs other than the study drug or the control drug during the healing phase
17.Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator

Related Information

• Primary Sponsor: Akiyama Junichi
• Secondary Sponsor: Uemura Naomi,Takeda Pharmaceutical Company Limited,Takeda Pharmaceutical Company Limited
• Secondary ID(s): NCT02679508,JapicCTI-163153