Erosive Esophagitis Clinical Trial
Official title:
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)
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.
This is a multicenter, open-label, randomized, parallel-group study to exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration of vonoprazan in maintenance treatment after healed EE, and the curative effect of vonoprazan versus lansoprazole in participants with EE. 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. If the principal investigator or investigator judged the effect of vonoprazan 10 mg or lansoprazole 15 mg to be insufficient as the maintenance treatment of EE, vonoprazan and lansoprazole may be increased to 20 mg and 30 mg, respectively. The research period will consist of two subperiods: healing phase in which participants with EE will receive treatment (for 4 or 8 weeks) and maintenance phase in which participants will receive maintenance treatment (for 260 weeks), and thus, a total of up to 268 weeks. The number of visits will be a maximum of 18 visits. Planned number of research subjects, as the number of research subjects for entry to the maintenance phase, will be 130 participants in the vonoprazan group and 65 participants in the lansoprazole group. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01452776 -
Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis
|
Phase 3 | |
Recruiting |
NCT05587309 -
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT04124926 -
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT01459367 -
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT00228527 -
Esomeprazole for Treatment of GERD in Pediatric Patients
|
Phase 4 | |
Completed |
NCT01499368 -
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
|
Phase 3 | |
Not yet recruiting |
NCT04613895 -
Treatment Effect According to Timing of Administration of DWP14012 40 mg
|
N/A | |
Recruiting |
NCT02615184 -
A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children
|
Phase 2 | |
Completed |
NCT02456935 -
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT02028663 -
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 2 | |
Completed |
NCT03006874 -
Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT02388724 -
Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT01865825 -
Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?
|
N/A | |
Recruiting |
NCT06391177 -
A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily
|
Phase 1 | |
Completed |
NCT05050188 -
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008
|
Phase 1 | |
Completed |
NCT01874535 -
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
|
Phase 4 | |
Completed |
NCT00206180 -
NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
|
Phase 4 | |
Completed |
NCT01630746 -
A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT01642615 -
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents
|
Phase 2 | |
Completed |
NCT01509261 -
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
|
Phase 3 |