Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety (NCT02679508) | Clinical Trial Compass
CompletedPhase 4
Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
Japan208 participantsStarted 2016-03-20
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
โ. 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)
โ. Participants with H. pylori negative
โ. 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.
โ. Participants who can sign and date an informed consent form and information sheet prior to the conduction of the clinical research procedures.
โ. Male or female participants aged 20 years or older at the time of informed consent
โ. Therapeutic category: Ambulatory
โ. 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)
โ. Participants who have been determined to be appropriate as subjects for maintenance treatment of EE by the principal investigator or investigator
Exclusion criteria
โ. Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison syndrome
โ. 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)
โ
What they're measuring
1
Number of Participants With Malignant Alteration of Epithelial Cells
Timeframe: Time Frame: Up to Week 268 (Week 260 in Maintenance Phase)
2
Number of Participants With Parietal Cell Protrusion/Hyperplasia
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)
3
Number of Participants With Foveolar Hyperplasia
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)
4
Number of Participants With Enterochromaffin-like-cell Hyperplasia
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)
5
Number of Participants With G-cell Hyperplasia
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)
. Participants with a history of H. pylori eradication.
โ. Participants who have received surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis \[excluding Schatzki's ring\], etc.)
โ. 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.
โ. 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).
โ. Participants with renal impairment or renal failure \[creatinine clearance (CCr) ห30 mL/min, etc.\]
โ. Participants with a history of hypersensitivity or allergy for PPIs.