Skip to main content
OpenTrials
Completed

NCT Number: NCT06778395

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zagazig University Hospital

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexlansoprazole 60 mg

Drug

once daily for 8 weeks

Vonoprazan 20 mg bid

Drug

twice daily for 8 weeks

Primary outcomes

  1. Symptom relief assessed by the GERD-Q score

    Time frame: 8 weeks

Secondary outcomes

  1. Frequency scale of the symptoms of gastroesophageal reflux disease questionnaire (FSSG)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Ayman Magd Eldin Mohammad Sadek

Other Gov

Collaborators

  • Zagazig University

Registry information

Official study title

Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease in Egyptian Patients: A Prospective Comparative Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.