Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-01-01 @ 7:12 AM
Study NCT ID:
NCT00808769
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2008-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C494109', 'term': 'omeprazole, sodium bicarbonate drug combination'}, {'id': 'D009853', 'term': 'Omeprazole'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcrorie.jw@pg.com', 'phone': '513-622-1423', 'title': 'John Mcrorie, PhD, FACG, AGAF', 'organization': 'The Procter & Gamble Company'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Results of this study were uninterpretable as noted in the Analysis Population Description.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Zegerid® Then Prilosec OTC®', 'description': 'Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prilosec OTC® Then Zegerid®', 'description': 'Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Mean Percent Time Gastric pH > 4.0 on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zegerid® Then Prilosec OTC®', 'description': 'Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)'}, {'id': 'OG001', 'title': 'Prilosec OTC® Then Zegerid®', 'description': 'Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)'}], 'timeFrame': 'continuously over a 24 hour period', 'description': 'In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \\< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zeros are entered because the data are corrupted for 2 reasons: probe calibration failure rate was \\~10x higher than historically documented, and the probes that calibrated had a high incidence of prolonged pH \\< 1.0 (highly physiologically improbable). This calls into question the credibility and interpretability of all the pH data.', 'anticipatedPostingDate': '2010-02'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zegerid® Then Prilosec OTC®', 'description': 'Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)'}, {'id': 'FG001', 'title': 'Prilosec OTC® Then Zegerid®', 'description': 'Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study period of this study was November 25 to December 21, 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '4.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The study was a cross-over study with 30 subjects receiving each treatment; therefore, baseline characteristics are identical for each treatment.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2008-12-15', 'resultsFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-29', 'studyFirstPostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Mean Percent Time Gastric pH > 4.0 on Day 1', 'timeFrame': 'continuously over a 24 hour period', 'description': 'In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \\< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Normal Healthy Subject Population']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal subjects who are 18-65 years of age;\n* Non-childbearing potential females or those using birth control\n\nExclusion Criteria:\n\n* History of significant GI disease\n* Any significant medical illness\n* History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors;\n* Currently using GI medications\n* GI disorder or surgery leading to impaired drug absorption'}, 'identificationModule': {'nctId': 'NCT00808769', 'briefTitle': 'Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression', 'orgStudyIdInfo': {'id': '2008122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Zegerid®', 'interventionNames': ['Drug: Zegerid®']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Prilosec OTC®', 'interventionNames': ['Drug: Prilosec OTC®']}], 'interventions': [{'name': 'Zegerid®', 'type': 'DRUG', 'description': 'capsule(20 mg omeprazole/sodium bicarbonate), single dose', 'armGroupLabels': ['1']}, {'name': 'Prilosec OTC®', 'type': 'DRUG', 'description': 'Omeprazole-magnesium 20.6 mg, tablet, single dose', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'John McRorie, PhD, FACG, AGAF', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Procter and Gamble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}