Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-18 @ 4:48 PM
Study NCT ID:
NCT07267260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Post-Endoscopic Variceal Band Ligation (EVBL) Ulcers', 'timeFrame': 'At follow-up endoscopy, 14 ± 1 days after EVBL.', 'description': 'The proportion of participants who develop visible post-banding ulcers detected on follow-up endoscopy. Ulcers will be assessed using the Lanza Score for gastric mucosal injury, which grades the number and severity of ulcers from 0 (no injury) to 4 (severe injury). A lower Lanza score indicates less mucosal injury. The outcome compares the rate and severity of ulcers between the vonoprazan and placebo groups.'}], 'secondaryOutcomes': [{'measure': 'Change in Dysphagia, Odynophagia, and Retrosternal Pain Scores on Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and 14 ± 1 days after EVBL.', 'description': 'Change in symptom intensity for swallowing pain (odynophagia), difficulty swallowing (dysphagia), and chest discomfort (retrosternal pain), measured using a 100 mm Visual Analog Scale (VAS) where 0 = no pain and 100 = worst possible pain. The change from baseline to day 14 will be calculated. A ≥ 20% reduction in VAS score from baseline will be considered clinically significant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vonoprazan', 'Potassium-competitive acid blocker', 'Endoscopic variceal band ligation', 'Esophageal varices', 'Post-procedure ulcer', 'Cirrhosis', 'Portal hypertension', 'Double-blind randomized controlled trial'], 'conditions': ['Cirrhoses, Liver']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the medicine vonoprazan can help prevent ulcers that may develop after endoscopic variceal band ligation (EVBL) in adults with liver cirrhosis. These ulcers sometimes cause pain or delayed bleeding after the procedure.\n\nThe study will also look at how well vonoprazan is tolerated and if it improves comfort after the procedure.\n\nThe main questions this study will answer are:\n\nDoes vonoprazan lower the number and severity of ulcers found on endoscopy after EVBL?\n\nDoes vonoprazan reduce swallowing pain or chest discomfort compared with placebo?\n\nIs vonoprazan safe and well tolerated in people with liver cirrhosis?\n\nResearchers will compare vonoprazan 20 mg once daily with a placebo (a look-alike tablet that contains no active medicine) to see if vonoprazan works better to prevent these ulcers.\n\nParticipants will:\n\nTake vonoprazan or placebo by mouth once daily for 14 days after EVBL.\n\nReturn for a follow-up endoscopy about two weeks later to check for ulcers.\n\nReport any symptoms such as pain, nausea, or swallowing difficulty during the study.\n\nAdults aged 18 to 75 years with liver cirrhosis who undergo EVBL will be invited to join. Participants will be randomly assigned to one of two groups, and neither they nor the study doctors will know which treatment they receive (double-blind design).\n\nThe study will take place at Mayo Hospital, Lahore, Pakistan, over about six months.\n\nBy comparing vonoprazan to placebo, researchers hope to find a better way to protect the esophagus and stomach after EVBL, reduce post-procedure pain, and support faster recovery in people with liver cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 75 years (male or female)\n* Diagnosis of liver cirrhosis confirmed by clinical, biochemical, or imaging findings.\n* Presence of documented esophageal varices requiring endoscopic variceal band ligation (EVBL).\n* Able and willing to provide written informed consent in English or Urdu.\n* Willing to comply with study procedures, including taking study medication and attending follow-up endoscopy.\n\nExclusion Criteria:\n\n* History of gastric or esophageal surgery\n* Allergy or contraindication to vonoprazan or study drug components\n* Pregnant or lactating women\n* Individuals who are non-cooperative or unable to understand local languages\n* Critically ill patients, including:\n\nICU admission Requirement for mechanical ventilation GCS \\< 10\n\n* Active gastrointestinal bleeding at the time of enrollment\n* Malignancy of the upper gastrointestinal tract'}, 'identificationModule': {'nctId': 'NCT07267260', 'briefTitle': 'Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '640/RC/KEMU Dated: 28/08/25'}, 'secondaryIdInfos': [{'id': '640/RC/KEMU', 'type': 'OTHER', 'domain': 'IRB King Edward Medical University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vonoprazan 20 mg after EVBL', 'description': 'Participants in this arm will receive vonoprazan 20 mg orally once daily for 14 days following endoscopic variceal band ligation (EVBL). Vonoprazan is a potassium-competitive acid blocker that provides strong and sustained suppression of gastric acid. The aim is to test whether vonoprazan can help prevent the formation of ulcers that sometimes develop after EVBL and to improve symptoms such as pain or difficulty swallowing. Participants will continue their usual medical care for liver disease. Study staff, participants, and investigators will all remain blinded to treatment allocation until data analysis is complete.', 'interventionNames': ['Drug: Vonoprazan 20 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo after EVBL', 'description': 'Participants in this arm will receive a placebo tablet orally once daily for 14 days following endoscopic variceal band ligation (EVBL). The placebo tablet will look identical to the Vonoprazan tablet but contains no active medicine. This group serves as a comparison to determine whether Vonoprazan is more effective than placebo in preventing post-procedural ulcers and reducing symptoms such as swallowing discomfort or chest pain. Participants will receive standard medical care for liver disease and will undergo the same follow-up and assessments as the experimental group.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vonoprazan 20 mg', 'type': 'DRUG', 'otherNames': ['Potassium-competitive acid blocker', 'TAK-438'], 'description': 'Vonoprazan is a potassium-competitive acid blocker (P-CAB) that provides strong and sustained suppression of gastric acid secretion. In this study, participants will receive vonoprazan 20 mg by mouth once daily for 14 days after endoscopic variceal band ligation (EVBL). The tablets will be taken with water, preferably before breakfast. This dose and duration are based on prior clinical experience in acid-related disorders. The aim is to determine whether vonoprazan prevents the formation of ulcers and reduces post-procedure pain compared with placebo.', 'armGroupLabels': ['Vonoprazan 20 mg after EVBL']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Inactive tablet'], 'description': 'Participants in the placebo group will receive a look-alike oral tablet with no active medicine, once daily for 14 days after EVBL. The placebo will be identical in color, size, and packaging to the Vonoprazan tablet to maintain blinding. This comparator will help determine whether Vonoprazan provides any true benefit in preventing ulcers and improving symptoms beyond standard post-procedure care.', 'armGroupLabels': ['Placebo after EVBL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Sheikh', 'role': 'CONTACT', 'email': 'dr.usheikh@gmail.com', 'phone': '03219994005'}], 'facility': 'King Edward Medical University/Mayo Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Muhammad R Tariq, MBBS,FCPS', 'role': 'CONTACT', 'email': 'ibneislam190@gmail.com', 'phone': '+923337692728'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared publicly because this is a single-center academic study conducted at Mayo Hospital, Lahore, with a limited sample size and locally collected data. De-identified summary data and statistical analyses may be made available upon reasonable request to the principal investigator after publication of study results, in accordance with institutional and ethical committee policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Edward Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rizwan Tariq Neuro', 'investigatorAffiliation': 'King Edward Medical University'}}}}