Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:07 AM
Study NCT ID:
NCT07437768
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-27
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vonoprazan Test for PPI Refractory GERD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-10-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All participants were evaluated using the following validated symptom questionnaires: The GERD Questionnaire', 'timeFrame': '4 weeks', 'description': 'The GERD Questionnaire (GerdQ) includes 4 positive predictors (heartburn, regurgitation, reflux-related sleep disturbance, and use of over-the-counter medications) and 2 negative predictors (epigastric pain and nausea) for GERD.\n\nThe GerdQ score ranges from 0 to 18. A higher score indicates a higher probability of GERD and a greater symptom burden. A cutoff score of 8 or higher is generally used to identify patients with a high likelihood of having GERD.'}], 'secondaryOutcomes': [{'measure': 'The Reflux Symptom Index (RSI)', 'timeFrame': '4 weeks', 'description': 'The Reflux Symptom Index (RSI) consists of 9 items (e.g., hoarseness, frequent throat clearing, and globus sensation), each rated on a scale from 0 (no problem) to 5 (severe) based on the severity of symptoms.\n\nMinimum score: 0\n\nMaximum score: 45'}, {'measure': 'The 5-item Brief Symptom Rating Scale (BSRS-5)', 'timeFrame': '4 weeks', 'description': 'The BSRS-5 score ranges from 0 to 20. A higher score indicates greater psychological distress.\n\nThe 5-item Brief Symptom Rating Scale (BSRS-5) was used to screen for common psychiatric conditions, such as anxiety and depression; a score ≥ 6 indicates potential psychological morbidity.'}, {'measure': 'The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '4 weeks', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is a 7-item self-rated questionnaire used to assess sleep quality over the preceding month; a global PSQI score \\> 5 indicates poor sleep quality or sleep disturbance.\n\nThe PSQI global score ranges from 0 to 21. A higher score indicates poorer sleep quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory GERD', 'NERD', 'PCAB']}, 'descriptionModule': {'briefSummary': "Among patients suffering from gastroesophageal reflux disease (GERD) symptoms, esophageal pH monitoring and the assessment of symptom-reflux correlation can identify two distinct subgroups characterized by normal acid exposure: functional heartburn and reflux hypersensitivity. Given the absence of abnormal acid exposure in these groups, conventional antacid therapies often yield unsatisfactory clinical outcomes.\n\nTherefore, in cases of PPI-refractory GERD, it is hypothesized that patients with underlying abnormal acid reflux will respond to Vonoprazan, a more potent potassium-competitive acid blocker (P-CAB). Conversely, those whose symptoms are unrelated to acid reflux are expected to show poor response. For future refractory patients without definitive endoscopic evidence of GERD (such as Los Angeles Grade B, C, or D esophagitis, peptic stricture, or histologically confirmed Barrett's esophagus), a Vonoprazan therapeutic trial could potentially bypass the need for invasive high-resolution manometry (HRM) and 24-hour pH-impedance monitoring. Evaluating the efficacy of Vonoprazan may offer diagnostic insights while minimizing patient discomfort and reducing overall healthcare expenditures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged between 20 and 75 years.\n* Outpatients at Fu Jen Catholic University Hospital who had undergone esophagogastroduodenoscopy (EGD) within the past year.\n* Presence of persistent GERD symptoms, including acid regurgitation, heartburn, chest pain, globus sensation, or chronic cough. PPI-refractory GERD, defined as persistent symptoms despite receiving at least 8 weeks of standard-dose proton pump inhibitor (PPI) therapy (GerdQ \\> = 8).\n* Scheduled to undergo high-resolution manometry (HRM) and 24-hour esophageal pH-impedance monitoring.\n* Patients with a history of any grade of erosive esophagitis confirmed by gastroscopy.\n\nExclusion Criteria:\n\n* major esophageal motility disorders\n* history of upper gastrointestinal surgery\n* malignant tumors\n* liver cirrhosis.\n* esophageal strictures\n* esophageal varices\n* gastrointestinal obstruction\n* significant acute GI bleeding\n* LA Grade B, C, or D erosive esophagitis,\n* esophageal peptic stricture\n* biopsy-proven Barrett's esophagus\n* severe renal impairment (CrCl \\< 30 mL/min)\n* long-term dialysis, pregnancy\n* hypersensitivity to vonoprazan or its excipients.\n* patients currently taking atazanavir sulfate or rilpivirine hydrochloride,\n* dependent on tube feeding\n* unable to cooperate due to impaired consciousness"}, 'identificationModule': {'nctId': 'NCT07437768', 'briefTitle': 'Vonoprazan Test for PPI Refractory GERD', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University Hospital'}, 'officialTitle': 'Vonoprazan Test for Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'PCAB for GERD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'single arm. All patient received Vonoprazan', 'description': 'Patients scheduled for high-resolution manometry (HRM) and 24-hour esophageal pH-impedance monitoring due to GERD symptoms were invited to participate in this study. Following the attainment of informed consent, participants completed a series of GERD-related questionnaires on the day of their examination. Subsequently, they were prescribed a 4-week course of VOCINTI®, a potassium-competitive acid blocker (P-CAB), at a daily oral dose of vonoprazan 20 mg.\n\nAt the 4-week follow-up visit, the clinical reports for HRM and 24-hour pH-impedance monitoring were reviewed. During this visit, patients completed the GERD-related questionnaires for a second time. Subsequent therapeutic management was then determined based on the comprehensive diagnostic results.', 'interventionNames': ['Drug: Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)']}], 'interventions': [{'name': 'Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)', 'type': 'DRUG', 'description': 'Participants undergoing HRM and 24-hour pH-impedance monitoring were enrolled after providing informed consent. Baseline GERD-related questionnaires were administered on the day of the procedure. Patients then received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®). After four weeks, patients returned for a follow-up visit to review their diagnostic reports and complete a second set of questionnaires. Final treatment strategies were adjusted according to the test findings.', 'armGroupLabels': ['single arm. All patient received Vonoprazan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24352', 'city': 'New Taipei City', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Fu Jen Catholic University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}