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Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease

Phase 4
Completed
Conditions
Vonoprazan
Proton Pump Inhibitor
Gastroesophageal Reflux Disease
Interventions
Registration Number
NCT06778395
Lead Sponsor
Ayman Magd Eldin Mohammad Sadek
Brief Summary

Gastroenterologists are often hesitated about whether to use the well known PPI in treatment of GERD or the usage of new H/K ATPase inhibitors so its highly needed to test the benefit of each class in Egyptian population to help doctors in decision making

Detailed Description

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder that occurs when gastric contents reflux into the esophagus and oral cavity, resulting in troublesome symptoms and/or complications. These include heartburn, a burning sensation in the chest, acid regurgitation, or an ongoing cough. Serious complications include dysphagia and Barrett's esophagus, potentially leading to esophageal adenocarcinoma.

GERD is a common condition, often due to abnormalities in the lower esophageal sphincter, with a pooled global prevalence of 13.3% or more of the population reporting at least weekly symptoms with rates increasing; however, with appreciable geographical variation. As a result, GERD is typically the most frequent gastrointestinal disorder across countries, with consultation rates in ambulatory care ranging from 5.4% to 56% of all consultations. Although GERD cannot be classified as a single disease, it is often used as an umbrella term.

Endoscopy is used to identify GERD, as well as clinical signs including heartburn and acid regurgitation. The two types of GERD are either erosive or non-erosive reflux disease.

The main therapeutic option for GERD is proton pump inhibitors \[PPIs\], which are superior to other medications in terms of symptom alleviation and mucosal healing. PPIs are known as first-line treatments in individuals with GERD.

Dexlansoprazole, which is the seventh proton pump inhibitor (PPI) to enter the market, is currently one of six PPIs available. It has been used clinically in various formulations as a racemic mixture. The chemical structure of lansoprazole contains an asymmetric sulfinyl group with a chiral center, resulting in two enantiomers, R (+) and S (-). Dexlansoprazole is the R-enantiomer. While the R and S isomers exhibit comparable pharmacological characteristics, research conducted in laboratory settings and living organisms has revealed that the dominant factor behind the inhibitory effects of racemic lansoprazole on the secretion of gastric acid is mainly dexlansoprazole.

Vonoprazan is known as a new family in the suppression of gastric acid which is a potassium-competitive acid blocker \[P-CABs\]. In comparison to PPIs, P-CABs reversibly inhibit H+ and K+ ATPase, resulting in a great and long-term suppression of acid secretion. As reported in some studies, the rate of healing of reflux esophagitis was superior to that of a PPI \[lansoprazole\], with a greater effect seen in cases with greater severity.

P-CABs act faster than PPIs and reach their peak in acid inhibition impact post-treatment, whereas PPIs take three to five days. However, few researchers have looked at whether Vonoprazan's faster affects the clinical impact on GERD symptoms of acid regurgitation as weak as heartburn.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
136
Inclusion Criteria
  • Confirmed diagnosis of GERD through upper endoscopy
Exclusion Criteria
  • Patients with a history of previous GERD surgery
  • Patients on any proton pump inhibitors (PPIs) or H2 blockers within 4 weeks prior to the study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DexlansoprazoleDexlansoprazole 60 mg60 mg once daily
VonoprazanVonoprazan 20 mg bid20 mg twice daily
Primary Outcome Measures
NameTimeMethod
Symptom relief assessed by the GERD-Q score8 weeks
Secondary Outcome Measures
NameTimeMethod
Frequency scale of the symptoms of gastroesophageal reflux disease questionnaire (FSSG)8 weeks

Trial Locations

Locations (1)

Zagazig University Hospital

🇪🇬

Zagazig, Sharkia, Egypt

Zagazig University Hospital
🇪🇬Zagazig, Sharkia, Egypt

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