Risk of Cancer Among Pantoprazole Users

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NCT01322633

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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.
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
  • 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 Status Completed
Actual Enrollment
 (submitted: March 23, 2011)		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:

  • 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
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2014