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ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophagitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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.
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Advanced Information
| 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 | |||