Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564246
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease
Detailed Description:
Gastroesophageal reflux disease GERD occurs when stomach acid repeatedly flows back into the esophagus with or without histological changes However the excessive reflux of gastric acid induces some complications such as esophagitis esophageal stenosis cancer or Barretts esophagus GERD is classified into two categories nonerosive reflux disease NERD and erosive esophagitis NERD is characterized by the presence of the typical symptoms of GERD without visible erosive esophagitis on endoscopy Erosive esophagitis is characterized by injury to the esophageal mucosa on endoscopy The major symptoms of GERD include heartburn acid regurgitation and decrease the patients quality of life QOL Therefore improvement in the QOL of these patients by supplying rapid relief of symptoms is the primary objective of treatment
For decades proton pump inhibitors PPIs have been the mainstay of treatment for erosive esophagitis Long-term maintenance therapy with PPIs is also recommended to keep healing in patients with more severe erosive esophagitis given that recurrence occurs in nearly 100 of such patients without therapy Furthermore PPIs are restricted in their time of dosing PPIs are prodrugs that are converted to their active form in the acidic environment of the secretory canaliculus which is also the sole location of active proton pumps in the parietal cell Thus PPIs only inhibit active proton pumps Given their limited duration of action half-life nearly 1-2 hours PPI are taken 30 to 60 minutes before a meal so their presence in the secretory canaliculus coincides with the postprandial peak in active proton pumps
An alternative therapy for patients who may not respond to PPIs and that does not have the requirement for dosing around meals might be of utility Such a potential alternative therapy is a potassium competitive acid blocker PCAB a new class of antisecretory agent that supplies more potent inhibition of gastric acid than PPI
PCAB exhibits a more rapid onset of action than PPIs and achieves a maximum acid inhibitory effect on the 1st day after treatment while PPIs require 3-5 days However few studies have examined whether the rapid onset of vonoprazan contributes to the clinical effects on the typical GERD symptoms of heartburn and acid regurgitation
The previously mentioned findings highlight the need for further studies to evaluate the role of vonoprazan in patients with gastroesophageal reflux disease
Aim of the Work The aim of this study is to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease
For decades proton pump inhibitors PPIs have been the mainstay of treatment for erosive esophagitis Long-term maintenance therapy with PPIs is also recommended to keep healing in patients with more severe erosive esophagitis given that recurrence occurs in nearly 100 of such patients without therapy Furthermore PPIs are restricted in their time of dosing PPIs are prodrugs that are converted to their active form in the acidic environment of the secretory canaliculus which is also the sole location of active proton pumps in the parietal cell Thus PPIs only inhibit active proton pumps Given their limited duration of action half-life nearly 1-2 hours PPI are taken 30 to 60 minutes before a meal so their presence in the secretory canaliculus coincides with the postprandial peak in active proton pumps
An alternative therapy for patients who may not respond to PPIs and that does not have the requirement for dosing around meals might be of utility Such a potential alternative therapy is a potassium competitive acid blocker PCAB a new class of antisecretory agent that supplies more potent inhibition of gastric acid than PPI
PCAB exhibits a more rapid onset of action than PPIs and achieves a maximum acid inhibitory effect on the 1st day after treatment while PPIs require 3-5 days However few studies have examined whether the rapid onset of vonoprazan contributes to the clinical effects on the typical GERD symptoms of heartburn and acid regurgitation
The previously mentioned findings highlight the need for further studies to evaluate the role of vonoprazan in patients with gastroesophageal reflux disease
Aim of the Work The aim of this study is to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None