Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT01286194
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
2011-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC) Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2011-01-28', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-28', 'lastUpdatePostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use', 'timeFrame': 'screening visit (Day 0 )'}, {'measure': 'The percentage of subjects who follow key directions for use (1 tablet per day, 14-day course of treatment, and no more than one course of treatment every 4 months)', 'timeFrame': '14 day treatment period; up to 4 months'}, {'measure': 'The percentage of subjects who make appropriate ongoing decisions about suitability for treatment (including consulting a physician and appropriately modifying or discontinuing use based on label directions)', 'timeFrame': '14 day treatment period; up to 4 months'}, {'measure': 'The percentage of subjects who experience serious / non-serious adverse events', 'timeFrame': ': 14 day treatment period; up to 4 months'}]}, 'conditionsModule': {'conditions': ['Frequent Heartburn']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nTo be eligible for participation, consumers must:\n\n* Male or female, 18 years of age or older\n* Select and purchase the study medication for their own use\n* Be able to take part in periodic telephone interviews regarding their use of and experience with the medication\n* Give written informed consent for participation\n\nEXCLUSION CRITERIA Consumers will be excluded from participation if they meet any of the following criteria:\n\n* Allergic to rabeprazole\n* Currently have trouble or pain swallowing food\n* Currently have vomiting with blood\n* Currently have bloody or black stool\n* Currently pregnant or breast-feeding\n* Participated in a study regarding a heartburn medication during the last 12 months'}, 'identificationModule': {'nctId': 'NCT01286194', 'briefTitle': 'A Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC) Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Multi-Center, Open-Label, All-Comers, Single Group Observational Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC )Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms', 'orgStudyIdInfo': {'id': 'E3810-A001-315'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental 1', 'interventionNames': ['Drug: Rabeprazole sodium']}], 'interventions': [{'name': 'Rabeprazole sodium', 'type': 'DRUG', 'description': 'Rabeprazole sodium 10 mg orally every day for 14 days', 'armGroupLabels': ['Experimental 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Civic Center Pharmacy', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '30224', 'city': 'Griffin', 'state': 'Georgia', 'country': 'United States', 'facility': "Wynn's Pharmacy, Inc.", 'geoPoint': {'lat': 33.24678, 'lon': -84.26409}}, {'zip': '30045', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Monfort Drug Company, Inc.', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '30064', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eckerd Drug #234', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '66103', 'city': 'Kansas Ciry', 'state': 'Kansas', 'country': 'United States', 'facility': 'The Medicine Shoppe'}, {'zip': '66209', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Stark Pharmacy', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '55304', 'city': 'Andover', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Goodrich Pharmacy', 'geoPoint': {'lat': 45.2333, 'lon': -93.29134}}, {'zip': '55303', 'city': 'Anoka', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Goodrich Pharmacy', 'geoPoint': {'lat': 45.19774, 'lon': -93.38718}}, {'zip': '5544955449', 'city': 'Blaine', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Goodrich Pharmacy', 'geoPoint': {'lat': 45.1608, 'lon': -93.23495}}, {'zip': '55330', 'city': 'Elk River', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Goodrich Pharmacy', 'geoPoint': {'lat': 45.30385, 'lon': -93.56718}}, {'zip': '55070', 'city': 'Saint Francis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Goodrich Pharmacy', 'geoPoint': {'lat': 45.38691, 'lon': -93.3594}}, {'zip': '64116', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'North Oak Pharmacy', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64504', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Stevenson Family Pharmacy', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '64485', 'city': 'Savannah', 'state': 'Missouri', 'country': 'United States', 'facility': 'Countryside Pharmacy', 'geoPoint': {'lat': 39.94166, 'lon': -94.83025}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Family Prescription Center', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '76645', 'city': 'Hillsboro', 'state': 'Texas', 'country': 'United States', 'facility': 'T.B. Bond Pharmacy', 'geoPoint': {'lat': 32.01099, 'lon': -97.13001}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Studewood Pharmacy', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77020', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Kashmere Pharmacy', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75662', 'city': 'Kilgore', 'state': 'Texas', 'country': 'United States', 'facility': 'Longhorn Drug Company', 'geoPoint': {'lat': 32.38626, 'lon': -94.87577}}, {'zip': '75602', 'city': 'Longview', 'state': 'Texas', 'country': 'United States', 'facility': 'Louis Morgan Drug #1', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}, {'zip': '77379', 'city': 'Spring', 'state': 'Texas', 'country': 'United States', 'facility': 'The Medicine Shoppe #1511', 'geoPoint': {'lat': 30.07994, 'lon': -95.41716}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'West Houston Pharmacy', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', 'country': 'United States', 'facility': 'Mountain View Pharmacy', 'geoPoint': {'lat': 40.88939, 'lon': -111.88077}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Gibson United Drug', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84102', 'city': 'Salt Lake Ciry', 'state': 'Utah', 'country': 'United States', 'facility': 'Apothecary Shoppe'}, {'zip': '84105', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Jolley's Corner Pharmacy #1", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Family Plaza Pharmacy', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '23192', 'city': 'Montpelier', 'state': 'Virginia', 'country': 'United States', 'facility': 'Montpelier Pharmacy, Inc.', 'geoPoint': {'lat': 37.37654, 'lon': -77.15942}}, {'zip': '23221', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Lafayette Pharmacy', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Rxtracare/U & I Pharmacy', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98028', 'city': 'Kenmore', 'state': 'Washington', 'country': 'United States', 'facility': 'Ostrom Drugs', 'geoPoint': {'lat': 47.75732, 'lon': -122.24401}}, {'zip': '98148', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Manhattan Drug', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98290', 'city': 'Snohomish', 'state': 'Washington', 'country': 'United States', 'facility': "Kusler's Pharmacy", 'geoPoint': {'lat': 47.91288, 'lon': -122.09818}}], 'overallOfficials': [{'name': 'Marco Cyrille, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Marco Cyrille, MD', 'oldOrganization': 'Eisai, Inc'}}}}