Clinical trial NCT06778395: Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease
Official title: Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease in Egyptian Patients: A Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vonoprazan
Proton Pump Inhibitor
Gastroesophageal Reflux Disease
Keywords: Dexlansoprazole
gastroesophageal reflux disease
Vonoprazan
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
Collaborators: name: Zagazig University
First posted: 2025-01-16
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symptom relief assessed by the GERD-Q score
timeFrame: 8 weeks
Secondary outcomes:
measure: Frequency scale of the symptoms of gastroesophageal reflux disease questionnaire (FSSG)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospital
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Ayman Sadek, MD
role: STUDY_CHAIR
References:
citation: Cheng Y, Liu J, Tan X, Dai Y, Xie C, Li X, Lu Q, Kou F, Jiang H, Li J. Direct Comparison of the Efficacy and Safety of Vonoprazan Versus Proton-Pump Inhibitors for Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2021 Jan;66(1):19-28. doi: 10.1007/s10620-020-06141-5. Epub 2020 Feb 24.
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