Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease

December 4, 2024 updated by: Aya Hany Abdelaziz Fahmy, Tanta University
This study aims to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Barrett's 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 patient's 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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Theodore Billiharz Institute for Researchs
        • Principal Investigator:
          • Aya Hany Abdel Aziz, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 17-60 years.
  • Both genders.
  • Patients with a score ≥ 8 on the Gastroesophageal Reflux Disease Questionnaire (Gerd Q) are defined as having GERD and will enroll in this study and it will be done at baseline and after 8 weeks.

Exclusion Criteria:

  • Subjects with history of gastrointestinal disease, gastroduodenal surgery, inflammatory bowel disease and Barrett's esophagus.
  • Subjects with an earlier or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders (gastric or duodenal ulcer).
  • Subjects with history of total/subtotal gastrectomy and esophageal achalasia.
  • Subjects with Corona virus disease (COVID19).
  • Subjects with major cardiological, respiratory, endocrine metabolic disease and neuro-psychological disease.
  • Pregnancy or lactation.
  • Subjects with total bilirubin level ≥ 1.2 mg/dl and ALT level > 100 IU/l.
  • Subjects with renal impairment (Crcl less than 30 ml/min).
  • Patients receiving atazanavir sulphate, nelfinavir and rilpivirine hydrochloride due to potential drug interactions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vonoprazan 20mg (Vonseca)
• Group 1 (control group): 22 patients who will receive Vonoprazan 20mg (Vonseca) and placebo of pantoprazole (pantoloc) daily for 8 weeks
Drug: Vonoprazan 20 mg versus Pantoprazole 40 mg
Patients divided into two arms First Arm administered vonoprazan Second arm administered pantoprazole
Other Names:
  • Vononoprazan (Vonesca) versus pantoprazole (pantoloc)
Active Comparator: Pantoprazole 40 mg (Pantoloc)
• Group 2: 22 patients who will receive Pantoprazole 40 mg (Pantoloc) and placebo of vonoprazan (vonseca) daily for 8 weeks.
Drug: Vonoprazan 20 mg versus Pantoprazole 40 mg
Patients divided into two arms First Arm administered vonoprazan Second arm administered pantoprazole
Other Names:
  • Vononoprazan (Vonesca) versus pantoprazole (pantoloc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the measured biomarker
Time Frame: Before and after 2 months
Measured biomarkers are serum gastrin hormone and E-Cadherin level
Before and after 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gastroesophageal reflux disease symptoms (The Structured Assessment of Gastrointestinal Symptoms Questionnaire).
Time Frame: Before and after 2 months

Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) is a validated measure of the intensity and impact of 22 upper and lower gastrointestinal symptoms. Responses are given on a 5 point Likert scale from no problem, mild (can be ignored when you do not think about it), moderate (cannot be ignored, but does not influence daily activities), severe (influencing your concentration on daily activities) and very severe (markedly influences your daily activities

&/or requires rest) problem. In addition the SAGIS asks about the presence of selected non gastrointestinal symptoms including headache, chronic fatigue, back pain, sleep disturbances, depression and anxiety. The patient also answers the following questions, "In your own words, what is your most important health concern or problem?" and "In your own words, what is your second most important health concern or problem?
Before and after 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Aya Hany Abdel Aziz, Master degree student at faculty of pharmacy - Tanta university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

August 18, 2024

First Submitted That Met QC Criteria

August 18, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT(829)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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