Risk of Cancer Among Pantoprazole Users

NCT01322633 | Completed Results

• 2 other identifiers: 3001A1-100034B1791018
• Study Type: observational
• Target: 61,864
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophagitis

Keywords

Pantoprazole; proton pump inhibitor; gastric cancer; digestive system cancer; cancer

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Gastric Cancer

  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.

  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)

Secondary Outcomes (2)

• Incidence Rate of Composite Gastrointestinal Cancers

  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 of Overall Cancer

  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)

Study Arms (2)

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

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

Interventions

Does not apply OTHER

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

Pantoprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Esophagitis; Stomach Neoplasms; Digestive System Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Neoplasms; Neoplasms by Site; Stomach Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: July 1, 2004
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 20, 2014
• Results First Posted: February 20, 2014

Record last verified: 2014-01