Erosive esophagitis
Conditions
Interventions
investigational material(s)
Generic name etc : Vonoprazan
INN of investigational material : Vonoprazan
Therapeutic category code : 232 Agents for peptic ulcer
Dosage and Administration for Investigati
Sponsors
Akiyama Junichi
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of Participants with Malignant Alteration of Epithelial Cells Timeframe: Up to Week 268 (Week 260 in Maintenance Phase) 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. 2.Number of Participants with Parietal Cell Protrusion/Hyperplasia Timeframe: Up to Week 268 (Week 260 in Maintenance Phase) 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. 3.Number of Participants with Foveolar Hyperplasia Timeframe: Up to Week 268 (Week 260 in Maintenance Phase) 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. 4.Number of Participants with Enterochromaffin-like-cell Hyperplasia Timeframe: Up to Week 268 (Week 260 in Maintenance Phase) 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. 5.Number of Participants with G-cell Hyperplasia Timeframe: Up to Week 268 (Week 260 in Maintenance Phase) 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 histopatholo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of Participants with Recurrence of Erosive Esophagitis (EE) Time Frame: Up to Week 268 (Week 260 in Maintenance Phase) Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades O and A to D) during the Maintenance Phase. The LA classification graded as follows- Grade O: normal mucosa; Grade A: nonconfluent mucosal breaks =5mm in length; Grade C: confluent mucosal breaks 75% circumferential. 2.Percentage of Participants who Healed EE at the End of the Healing Phase Time Frame: Up to Week 8 Percentage of participants who healed EE at the end of healing phase was reported. 3.Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase Time Frame: 260 weeks (Baseline, up to the end of Maintenance Phase) Number of participants reporting one or more TEAEs in Maintenance Phase was reported. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. 4.Number of Participants with Fundic Gland Polyp Timeframe: Up to Week 268 (Week 260 in Maintenance Phase) Numbers of participants with fundic gland polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. 5.Number of Participants with Hyperplastic Polyp Timeframe: Up to Week 268 (Week 260 in Maintenance Phase) Numbers of p | — |
Countries
Japan
Outcome results
None listed