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Risk of Cancer Among Pantoprazole Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01322633
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : February 20, 2014
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Esophagitis Other: Does not apply

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

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Study Type : Observational
Actual Enrollment : 61864 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users
Study Start Date : July 2004
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pantoprazole
Patients who received treatment with pantoprazole tablets for at least 240 days within a 12-month period from 2000 through 2003.
Other: Does not apply
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.
Other: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply.




Primary Outcome Measures :
  1. Incidence Rate of Gastric Cancer [ Time Frame: 1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5) ]
    Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.


Secondary Outcome Measures :
  1. Incidence Rate of Composite Gastrointestinal Cancers [ Time Frame: 1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5) ]
    Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.

  2. Incidence Rate of Overall Cancer [ Time Frame: 1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5) ]
    Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322633


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01322633    
Other Study ID Numbers: 3001A1-100034
B1791018
First Posted: March 24, 2011    Key Record Dates
Results First Posted: February 20, 2014
Last Update Posted: February 20, 2014
Last Verified: January 2014
Keywords provided by Pfizer:
Pantoprazole
proton pump inhibitor
gastric cancer
digestive system cancer
cancer
Additional relevant MeSH terms:
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Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis