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This study aims to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan 20mg (Vonseca) | Active Comparator | • Group 1 (control group): 22 patients who will receive Vonoprazan 20mg (Vonseca) and placebo of pantoprazole (pantoloc) daily for 8 weeks |
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| Pantoprazole 40 mg (Pantoloc) | Active Comparator | • Group 2: 22 patients who will receive Pantoprazole 40 mg (Pantoloc) and placebo of vonoprazan (vonseca) daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan 20 mg versus Pantoprazole 40 mg | Drug | Patients divided into two arms First Arm administered vonoprazan Second arm administered pantoprazole |
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| Measure | Description | Time Frame |
|---|---|---|
| change in the measured biomarker | Measured biomarkers are serum gastrin hormone and E-Cadherin level | Before and after 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gastroesophageal reflux disease symptoms (The Structured Assessment of Gastrointestinal Symptoms Questionnaire). | 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? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya Hany Abdel Aziz, Bachelor | Contact | +201144818823 | PG_172956@pharm.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Aya Hany Abdel Aziz | Master degree student at faculty of pharmacy - Tanta university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theodore Billiharz Institute for Researchs | Recruiting | Giza | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16015691 | Background | Kim YS, Kim TH, Choi CS, Shon YW, Kim SW, Seo GS, Nah YH, Choi MG, Choi SC. Effect of itopride, a new prokinetic, in patients with mild GERD: a pilot study. World J Gastroenterol. 2005 Jul 21;11(27):4210-4. doi: 10.3748/wjg.v11.i27.4210. | |
| 30415407 | Background | Sakurai K, Suda H, Fujie S, Takeichi T, Okuda A, Murao T, Hasuda K, Hirano M, Ito K, Tsuruta K, Hattori M. Short-Term Symptomatic Relief in Gastroesophageal Reflux Disease: A Comparative Study of Esomeprazole and Vonoprazan. Dig Dis Sci. 2019 Mar;64(3):815-822. doi: 10.1007/s10620-018-5365-0. Epub 2018 Nov 10. |
| Label | URL |
|---|---|
| Almutairi MB, Alsulaimi SM, Alghamdi RA, et al. Evaluation of GERD Diagnosis, Management, and Outcomes. The Egyptian Journal of Hospital Medicine. 2018 ;72(9):5195-5202. | View source |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
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single blinded study
|
| Before and after 2 months |
| 24151376 | Background | Altomare A, Guarino MP, Cocca S, Emerenziani S, Cicala M. Gastroesophageal reflux disease: Update on inflammation and symptom perception. World J Gastroenterol. 2013 Oct 21;19(39):6523-8. doi: 10.3748/wjg.v19.i39.6523. |
| 10780570 | Background | Armstrong D. Endoscopic evaluation of gastro-esophageal reflux disease. Yale J Biol Med. 1999 Mar-Jun;72(2-3):93-100. |
| 19107335 | Background | Hongo M, Kinoshita Y, Miwa H, Ashida K. The demographic characteristics and health-related quality of life in a large cohort of reflux esophagitis patients in Japan with reference to the effect of lansoprazole: the REQUEST study. J Gastroenterol. 2008;43(12):920-7. doi: 10.1007/s00535-008-2257-7. Epub 2008 Dec 24. |
| 16098002 | Background | Pace F, Negrini C, Wiklund I, Rossi C, Savarino V; ITALIAN ONE INVESTIGATORS STUDY GROUP. Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2005 Aug 15;22(4):349-56. doi: 10.1111/j.1365-2036.2005.02558.x. |
| 36228734 | Background | Laine L, DeVault K, Katz P, Mitev S, Lowe J, Hunt B, Spechler S. Vonoprazan Versus Lansoprazole for Healing and Maintenance of Healing of Erosive Esophagitis: A Randomized Trial. Gastroenterology. 2023 Jan;164(1):61-71. doi: 10.1053/j.gastro.2022.09.041. Epub 2022 Oct 10. |
| 23350044 | Background | Shin JM, Kim N. Pharmacokinetics and pharmacodynamics of the proton pump inhibitors. J Neurogastroenterol Motil. 2013 Jan;19(1):25-35. doi: 10.5056/jnm.2013.19.1.25. Epub 2013 Jan 8. |
| 33592125 | Background | Abdel-Aziz Y, Metz DC, Howden CW. Review article: potassium-competitive acid blockers for the treatment of acid-related disorders. Aliment Pharmacol Ther. 2021 Apr;53(7):794-809. doi: 10.1111/apt.16295. Epub 2021 Feb 16. |
| 35294415 | Background | Laine L, Sharma P, Mulford DJ, Hunt B, Leifke E, Smith N, Howden CW. Pharmacodynamics and Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan and the Proton Pump Inhibitor Lansoprazole in US Subjects. Am J Gastroenterol. 2022 Jul 1;117(7):1158-1161. doi: 10.14309/ajg.0000000000001735. Epub 2022 Mar 16. |
| 28551709 | Background | Koloski NA, Jones M, Hammer J, von Wulffen M, Shah A, Hoelz H, Kutyla M, Burger D, Martin N, Gurusamy SR, Talley NJ, Holtmann G. The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting. Dig Dis Sci. 2017 Aug;62(8):1913-1922. doi: 10.1007/s10620-017-4599-6. Epub 2017 May 27. |
| D004066 | Digestive System Diseases |