Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Interventions
- Registration Number
- NCT06564246
- Lead Sponsor
- Tanta University
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vonoprazan 20mg (Vonseca) Vonoprazan 20 mg versus Pantoprazole 40 mg • Group 1 (control group): 22 patients who will receive Vonoprazan 20mg (Vonseca) and placebo of pantoprazole (pantoloc) daily for 8 weeks Pantoprazole 40 mg (Pantoloc) Vonoprazan 20 mg versus Pantoprazole 40 mg • Group 2: 22 patients who will receive Pantoprazole 40 mg (Pantoloc) and placebo of vonoprazan (vonseca) daily for 8 weeks.
- Primary Outcome Measures
Name Time Method change in the measured biomarker Before and after 2 months Measured biomarkers are serum gastrin hormone and E-Cadherin level
- Secondary Outcome Measures
Name Time Method Change in gastroesophageal reflux disease symptoms (The Structured Assessment of Gastrointestinal Symptoms Questionnaire). 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?
Trial Locations
- Locations (1)
Theodore Billiharz Institute for Researchs
🇪🇬Giza, Egypt