Risk of Cancer Among Pantoprazole Users

NCT ID: NCT01322633

Last Updated: 2014-02-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61864 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2013-03-31

Brief Summary

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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

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All subjects who met the inclusion criteria were included in the study.

Conditions

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Esophagitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pantoprazole

Patients who received treatment with pantoprazole tablets for at least 240 days within a 12-month period from 2000 through 2003.

Does not apply

Intervention Type OTHER

This is a non-interventional study, therefore the intervention type / name do 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.

Does not apply

Intervention Type OTHER

This is a non-interventional study, therefore the intervention type / name do not apply.

Interventions

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Does not apply

This is a non-interventional study, therefore the intervention type / name do not apply.

Intervention Type OTHER

Does not apply

This is a non-interventional study, therefore the intervention type / name do not apply.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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B1791018

Identifier Type: -

Identifier Source: secondary_id

3001A1-100034

Identifier Type: -

Identifier Source: org_study_id

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