Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 2:03 PM
Study NCT ID:
NCT01322633
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2011-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risk of Cancer Among Pantoprazole Users
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The study used de-identified patient-level electronic health related databases (e-HRD), in which it was not possible to link a particular product and medical event for any participant. Thus, minimum criteria for reporting an adverse event were not available and adverse events were not reportable as individual AE reports.', 'eventGroups': [{'id': 'EG000', 'title': 'Pantoprazole', 'description': 'Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Other Proton Pump Inhibitors (PPI)', 'description': 'Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Gastric Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34178', 'groupId': 'OG000'}, {'value': '27686', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.'}, {'id': 'OG001', 'title': 'Other Proton Pump Inhibitors (PPI)', 'description': 'Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.88', 'groupId': 'OG000', 'lowerLimit': '14.26', 'upperLimit': '26.96'}, {'value': '23.73', 'groupId': 'OG001', 'lowerLimit': '12.97', 'upperLimit': '39.81'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.93', 'groupDescription': 'Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)', 'description': 'Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.', 'unitOfMeasure': 'incidence per 100000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the inclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Composite Gastrointestinal Cancers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34178', 'groupId': 'OG000'}, {'value': '27686', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.'}, {'id': 'OG001', 'title': 'Other Proton Pump Inhibitors (PPI)', 'description': 'Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '168.41', 'groupId': 'OG000', 'lowerLimit': '151.13', 'upperLimit': '187.12'}, {'value': '129.25', 'groupId': 'OG001', 'lowerLimit': '101.84', 'upperLimit': '161.78'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.40', 'groupDescription': 'Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)', 'description': 'Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.', 'unitOfMeasure': 'incidence per 100000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the inclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Overall Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34178', 'groupId': 'OG000'}, {'value': '27686', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.'}, {'id': 'OG001', 'title': 'Other Proton Pump Inhibitors (PPI)', 'description': 'Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1465.21', 'groupId': 'OG000', 'lowerLimit': '1412.12', 'upperLimit': '1519.79'}, {'value': '1369.88', 'groupId': 'OG001', 'lowerLimit': '1275.12', 'upperLimit': '1469.82'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.21', 'groupDescription': 'Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)', 'description': 'Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.', 'unitOfMeasure': 'incidence per 100000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the inclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pantoprazole', 'description': 'Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.'}, {'id': 'FG001', 'title': 'Other Proton Pump Inhibitors (PPI)', 'description': 'Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34178'}, {'groupId': 'FG001', 'numSubjects': '27686'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34178'}, {'groupId': 'FG001', 'numSubjects': '27686'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34178', 'groupId': 'BG000'}, {'value': '27686', 'groupId': 'BG001'}, {'value': '61864', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pantoprazole', 'description': 'Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.'}, {'id': 'BG001', 'title': 'Other Proton Pump Inhibitors (PPI)', 'description': 'Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '71'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '71'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19033', 'groupId': 'BG000'}, {'value': '15611', 'groupId': 'BG001'}, {'value': '34644', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15145', 'groupId': 'BG000'}, {'value': '12075', 'groupId': 'BG001'}, {'value': '27220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all participants who met the inclusion criteria.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61864}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-07', 'studyFirstSubmitDate': '2011-03-23', 'resultsFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-07', 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Gastric Cancer', 'timeFrame': '1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)', 'description': 'Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.'}], 'secondaryOutcomes': [{'measure': 'Incidence Rate of Composite Gastrointestinal Cancers', 'timeFrame': '1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)', 'description': 'Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.'}, {'measure': 'Incidence Rate of Overall Cancer', 'timeFrame': '1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)', 'description': 'Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pantoprazole', 'proton pump inhibitor', 'gastric cancer', 'digestive system cancer', 'cancer'], 'conditions': ['Esophagitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3001A1-100034&StudyName=Risk%20of%20Cancer%20Among%20Pantoprazole%20Users%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess whether the risk of gastric cancer is increased in pantoprazole users compared to users of other proton pump inhibitors.', 'detailedDescription': 'All subjects who met the inclusion criteria were included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with long-term exposure to pantoprazole and other proton pump inhibitors enrolled in the Northern California Kaiser Permanente health maintenance organization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have used pantoprazole or other proton pump inhibitors, enrollment in the health maintenance organization for at least 6 months, age 18 years or older.\n\nExclusion Criteria:\n\n* Use of any proton pump inhibitor before study entry, any cancer diagnosis recorded in the medical history, diagnosis of Zollinger-Ellison Syndrome in medical history.'}, 'identificationModule': {'nctId': 'NCT01322633', 'briefTitle': 'Risk of Cancer Among Pantoprazole Users', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users', 'orgStudyIdInfo': {'id': '3001A1-100034'}, 'secondaryIdInfos': [{'id': 'B1791018'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pantoprazole', 'description': 'Patients who received treatment with pantoprazole tablets for at least 240 days within a 12-month period from 2000 through 2003.', 'interventionNames': ['Other: Does not apply']}, {'label': 'Other proton pump inhibitors', 'description': 'Patients who received treatment with any other proton pump inhibitor for at least 240 days within a 12-month period from 1996 through 2003.', 'interventionNames': ['Other: Does not apply']}], 'interventions': [{'name': 'Does not apply', 'type': 'OTHER', 'description': 'This is a non-interventional study, therefore the intervention type / name do not apply.', 'armGroupLabels': ['Pantoprazole']}, {'name': 'Does not apply', 'type': 'OTHER', 'description': 'This is a non-interventional study, therefore the intervention type / name do not apply.', 'armGroupLabels': ['Other proton pump inhibitors']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}