Esophagitis Clinical Trial
Official title:
Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users
Verified date | January 2014 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 61864 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Pfizer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence Rate of Gastric Cancer | 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. | 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) | Yes |
Secondary | Incidence Rate of Composite Gastrointestinal Cancers | 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. | 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) | Yes |
Secondary | Incidence Rate of Overall Cancer | 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. | 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) | Yes |
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