Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Esophagitis
Both
Esophagitis
Trial Information
Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users
All subjects who met the inclusion criteria were included in the study.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Risk of gastric cancer among pantoprazole users compared to users of other proton pump inhibitors during the follow-up period
Outcome Time Frame:
Up to 10 years
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3001A1-100034
NCT ID:
NCT01322633
Start Date:
July 2004
Completion Date:
September 2013
Related Keywords:
- Esophagitis
- Pantoprazole
- proton pump inhibitor
- gastric cancer
- digestive system cancer
- cancer
- Esophagitis
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