Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06955520
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
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': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor will be blinded for this study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis).', 'timeFrame': '8 weeks', 'description': 'This can be find during endoscopy test'}], 'secondaryOutcomes': [{'measure': '• Improvement in GERD-Q scores at 8 weeks', 'timeFrame': '8 weeks', 'description': 'GERD questionnaire can be calculated based on heart burn , regurgitation symptom scores which is scaled like 1 is very low symptoms, 5 is worse symptoms (outcome)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GERD']}, 'descriptionModule': {'briefSummary': 'Peroral Endoscopic Myotomy (POEM) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (GERD), with many patients developing LA grade B or higher esophagitis. Proton pump inhibitors (PPIs) like Esomeprazole are the standard treatment, but Vonaprazan, a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.\n\nPrimary Objective:\n\n• To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg.\n\nSecondary Objectives\n\n* To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks.\n* To evaluate the incidence of adverse events in each treatment group.', 'detailedDescription': 'Study Type:\n\n• Randomized, Open-Label, Two-Arm, Non-Inferiority Trial\n\nRandomization and Blinding:\n\n* Randomization: 1:1 ratio between Vonaprazan 20 mg and Esomeprazole 40 mg.\n* Stratification: Based on LA grade (B vs. C/D) at baseline.\n* Blinding: Open-label study, but outcome assessors will be blinded.\n\nStudy Timeline:\n\n1. All post-POEM patients receive Esomeprazole 40 mg for 2 months.\n2. PPI is discontinued for 1 month (to allow reflux esophagitis to develop if persistent GERD exists).\n3. At 3 months post-POEM, patients with LA grade B or higher esophagitis (on follow-up endoscopy) are randomized to either Vonaprazan 20 mg or Esomeprazole 40 mg for 8 weeks.\n4. At 8 weeks post-randomization (5 months post-POEM), healing of esophagitis is assessed.\n\nStudy Arms:\n\n* Arm A: Vonaprazan 20 mg once daily for 8 weeks\n* Arm B: Esomeprazole 40 mg once daily for 8 weeks\n\nStudy Procedures:\n\nBaseline Assessment (3 Months Post-POEM, Before Randomization)\n\n* Upper GI Endoscopy: Confirmation of LA grade B or higher reflux esophagitis.\n* GERD-Q Score assessment.\n* Randomization to Vonaprazan 20 mg or Esomeprazole 40 mg. Follow-Up (Week 4 - Interim Visit)\n* GERD-Q Score assessment.\n\nEnd-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM)\n\n* Upper GI Endoscopy to assess healing of reflux esophagitis.\n* GERD-Q Score reassessment.\n* Final adverse event reporting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years\n* History of POEM for achalasia\n* Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 months post-POEM\n* GERD symptoms (heartburn, regurgitation) for ≥4 weeks\n* Willingness to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* History of prior anti-reflux surgery\n* Presence of Barrett's esophagus, esophageal stricture, or malignancy\n* Severe gastroparesis or esophageal motility disorder unrelated to achalasia\n* Pregnancy or breastfeeding\n* Severe hepatic or renal impairment (ALT/AST \\>3× ULN, eGFR \\<30 mL/min)\n* Regular use of NSAIDs, steroids, or anticoagulants affecting esophageal healing"}, 'identificationModule': {'nctId': 'NCT06955520', 'briefTitle': 'Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM', 'orgStudyIdInfo': {'id': 'PFCNet 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug', 'description': 'healing rate will be checked during endoscopy at 8 weeks', 'interventionNames': ['Drug: Vonoprazan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'To see the healing rate of grade B esophagitis', 'description': 'healing rate will be checked during endoscopy at 8 weeks in patients receiving esomeprazole 40mg', 'interventionNames': ['Drug: Esomeprazole 40mg']}], 'interventions': [{'name': 'Vonoprazan', 'type': 'DRUG', 'otherNames': ['per oral endoscopy myotomy'], 'description': 'a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.', 'armGroupLabels': ['To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug']}, {'name': 'Esomeprazole 40mg', 'type': 'DRUG', 'otherNames': ['per oral endoscopy myotomy'], 'description': 'It is a proton pump inhibitor which reduces the excessive acid secretion in the stomach and it heals grade B esophagitis (\\>5mm ulcer between two mucosal folds in esophagus)', 'armGroupLabels': ['To see the healing rate of grade B esophagitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500082', 'city': 'Hyderabad', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'ZAHEER DR NABI, MBBS MDDNB', 'role': 'CONTACT', 'email': 'zaheernabi1978@gmail.com', 'phone': '04023378888', 'phoneExt': '503'}, {'name': 'Rajesh Goud Mr Maragoni, M.Pharm MBA', 'role': 'CONTACT', 'email': 'rajeshgoud761@gmail.com', 'phone': '04023378888', 'phoneExt': '301'}], 'facility': 'Asian Institute of Gastroenterology /Aig Hospitals', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'centralContacts': [{'name': 'Rajesh Goud Mr Maragoni, M.Pharm', 'role': 'CONTACT', 'email': 'rajeshgoud761@gmail.com', 'phone': '04023378888', 'phoneExt': '312'}, {'name': 'Zaheer Nabi Dr Mohammed, MD DNB', 'role': 'CONTACT', 'email': 'zaheernabi1978@gmail.com', 'phone': '04023378888', 'phoneExt': '427'}], 'overallOfficials': [{'name': 'Mohan Dr Ramchandani, MD DM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asian Institute of Gastroenterology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Mohan Ramchandani', 'investigatorAffiliation': 'Asian Institute of Gastroenterology, India'}}}}