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.
- 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.
- 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.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Risk of Cancer Among Pantoprazole Users | |||
| Official Title | Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users | |||
| Brief Summary | 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. | |||
| Detailed Description | All subjects who met the inclusion criteria were included in the study. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with long-term exposure to pantoprazole and other proton pump inhibitors enrolled in the Northern California Kaiser Permanente health maintenance organization. | |||
| Condition | Esophagitis | |||
| Intervention | Other: Does not apply This is a non-interventional study, therefore the intervention type / name do not apply. | |||
| Study Groups/Cohorts |
| |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 61864 | |||
| Original Estimated Enrollment | Same as current | |||
| Actual Study Completion Date | March 2013 | |||
| Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01322633 | |||
| Other Study ID Numbers | 3001A1-100034 B1791018 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2014 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
