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Risk of Cancer Among Pantoprazole Users

Last updated on November 16, 2019

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Study Location
Contact
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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.

NCT01322633
Pfizer
Completed
Risk of Cancer Among Pantoprazole Users

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Descriptive Information
Brief TitleRisk of Cancer Among Pantoprazole Users
Official TitleLong-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users
Brief SummaryThe 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 DescriptionAll subjects who met the inclusion criteria were included in the study.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with long-term exposure to pantoprazole and other proton pump inhibitors enrolled in the Northern California Kaiser Permanente health maintenance organization.
ConditionEsophagitis
InterventionOther: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply.
Study Groups/Cohorts
  • Pantoprazole
    Patients who received treatment with pantoprazole tablets for at least 240 days within a 12-month period from 2000 through 2003.
    Intervention: Other: Does not apply
  • Other proton pump inhibitors
    Patients who received treatment with any other proton pump inhibitor for at least 240 days within a 12-month period from 1996 through 2003.
    Intervention: Other: Does not apply
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 StatusCompleted
Actual Enrollment
 (submitted: March 23, 2011)
61864
Original Estimated EnrollmentSame as current
Actual Study Completion DateMarch 2013
Actual Primary Completion DateMarch 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01322633
Other Study ID Numbers3001A1-100034
B1791018
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2014

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

BY EMAIL

Contact

[email protected]

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