Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-28 @ 4:47 PM
Study NCT ID:
NCT06778395
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2025-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064748', 'term': 'Dexlansoprazole'}, {'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-01-12', 'studyFirstSubmitQcDate': '2025-01-12', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom relief assessed by the GERD-Q score', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Frequency scale of the symptoms of gastroesophageal reflux disease questionnaire (FSSG)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dexlansoprazole', 'gastroesophageal reflux disease', 'Vonoprazan'], 'conditions': ['Vonoprazan', 'Proton Pump Inhibitor', 'Gastroesophageal Reflux Disease']}, 'referencesModule': {'references': [{'pmid': '32095968', 'type': 'RESULT', '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.'}, {'pmid': '36117573', 'type': 'RESULT', 'citation': 'Zhang M, Xiao Y, Chen M. The role of vonoprazan in patients with erosive esophagitis. Therap Adv Gastroenterol. 2022 Sep 13;15:17562848221122623. doi: 10.1177/17562848221122623. eCollection 2022.'}, {'pmid': '36057730', 'type': 'RESULT', 'citation': 'Manabe N, Joh T, Higuchi K, Iwakiri K, Kamiya T, Haruma K, Nakada K. Clinical significance of gastroesophageal reflux disease with minimal change: a multicenter prospective observational study. Sci Rep. 2022 Sep 3;12(1):15036. doi: 10.1038/s41598-022-19408-w.'}, {'pmid': '33705573', 'type': 'RESULT', 'citation': "Eusebi LH, Telese A, Cirota GG, Haidry R, Zagari RM, Bazzoli F, Ford AC. Systematic review with meta-analysis: risk factors for Barrett's oesophagus in individuals with gastro-oesophageal reflux symptoms. Aliment Pharmacol Ther. 2021 May;53(9):968-976. doi: 10.1111/apt.16321. Epub 2021 Mar 11."}, {'pmid': '35979162', 'type': 'RESULT', 'citation': 'Turshudzhyan A, Samuel S, Tawfik A, Tadros M. Rebuilding trust in proton pump inhibitor therapy. World J Gastroenterol. 2022 Jun 28;28(24):2667-2679. doi: 10.3748/wjg.v28.i24.2667.'}, {'pmid': '28780072', 'type': 'RESULT', 'citation': 'Richter JE, Rubenstein JH. Presentation and Epidemiology of Gastroesophageal Reflux Disease. Gastroenterology. 2018 Jan;154(2):267-276. doi: 10.1053/j.gastro.2017.07.045. Epub 2017 Aug 3.'}, {'pmid': '34642267', 'type': 'RESULT', 'citation': 'Jung HK, Tae CH, Song KH, Kang SJ, Park JK, Gong EJ, Shin JE, Lim HC, Lee SK, Jung DH, Choi YJ, Seo SI, Kim JS, Lee JM, Kim BJ, Kang SH, Park CH, Choi SC, Kwon JG, Park KS, Park MI, Lee TH, Kim SY, Cho YS, Lee HH, Jung KW, Kim DH, Moon HS, Miwa H, Chen CL, Gonlachanvit S, Ghoshal UC, Wu JCY, Siah KTH, Hou X, Oshima T, Choi MY, Lee KJ; Korean Society of Neurogastroenterology and Motility. 2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease. J Neurogastroenterol Motil. 2021 Oct 30;27(4):453-481. doi: 10.5056/jnm21077.'}, {'pmid': '35184616', 'type': 'RESULT', 'citation': 'Al-Marhabi A, Hashem A, Zuberi BF, Onyekwere C, Lodhi I, Mounir M, Alkhowaiter S, Al Awadhi S, Naidoo VG, Hamada Y. The views of African and Middle Eastern Gastroenterologists on the management of mild-to-moderate, non-erosive gastro-esophageal reflux disease (GERD). Expert Rev Gastroenterol Hepatol. 2022 Mar;16(3):217-233. doi: 10.1080/17474124.2022.2043744. Epub 2022 Feb 25.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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.\n\nGERD 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.\n\nEndoscopy 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.\n\nThe 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.\n\nDexlansoprazole, 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.\n\nVonoprazan 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.\n\nP-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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of GERD through upper endoscopy\n\nExclusion Criteria:\n\n* Patients with a history of previous GERD surgery\n* Patients on any proton pump inhibitors (PPIs) or H2 blockers within 4 weeks prior to the study.'}, 'identificationModule': {'nctId': 'NCT06778395', 'briefTitle': 'Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease in Egyptian Patients: A Prospective Comparative Study', 'orgStudyIdInfo': {'id': 'ZU-IRB#745/5-Nov-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexlansoprazole', 'description': '60 mg once daily', 'interventionNames': ['Drug: Dexlansoprazole 60 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vonoprazan', 'description': '20 mg twice daily', 'interventionNames': ['Drug: Vonoprazan 20 mg bid']}], 'interventions': [{'name': 'Dexlansoprazole 60 mg', 'type': 'DRUG', 'description': 'once daily for 8 weeks', 'armGroupLabels': ['Dexlansoprazole']}, {'name': 'Vonoprazan 20 mg bid', 'type': 'DRUG', 'description': 'twice daily for 8 weeks', 'armGroupLabels': ['Vonoprazan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Zagazig University Hospital', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Ayman Sadek, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayman Magd Eldin Mohammad Sadek', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Zagazig University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Ayman Magd Eldin Mohammad Sadek', 'investigatorAffiliation': 'Zagazig University'}}}}