EsophagitisNCT01322633

Risk of Cancer Among Pantoprazole Users

An observational study of Esophagitis, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Esophagitis
What is being tested?: Does not apply
Type of treatment: Pill or oral medicine
How many people: 61,864 participants
Where: No sites listed yet
Study dates: Jul 2004to Mar 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with long-term exposure to pantoprazole and other proton pump inhibitors enrolled in the Northern California Kaiser Permanente health maintenance organization.

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users

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.

Read the detailed description

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

Conditions: Esophagitis
Being tested: Does not apply
Keywords: Pantoprazole, proton pump inhibitor, gastric cancer, digestive system cancer, cancer
Medical subject headings: Esophagitis, Stomach Neoplasms, Digestive System Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01322633
Study group	Role	What they receive
Pantoprazole		Patients who received treatment with pantoprazole tablets for at least 240 days within a 12-month period from 2000 through 2003. Receives: 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. Receives: Other: Does not apply

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2004Mar 2013

First posted24 Mar 2011 (estimated)
Study startJul 2004
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EsophagitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 61,864 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01322633
Sponsor's protocol ID: 3001A1-100034
Other IDs: B1791018
Status last verified: Jan 2014
First submitted: 23 Mar 2011
Last updated: 20 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach

All Esophagitis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users
ClinicalTrials.gov ID: NCT01322633
Acronym / sponsor ID: 3001A1-100034
Conditions: Esophagitis
Keywords: Pantoprazole, proton pump inhibitor, gastric cancer, digestive system cancer, cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 61,864 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2004
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 24 Mar 2011 (estimated)
Results: Posted 20 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Pantoprazole	–	Other: Does not applyPatients who received treatment with pantoprazole tablets for at least 240 days within a 12-month period from 2000 through 2003.
Other proton pump inhibitors	–	Other: Does not applyPatients who received treatment with any other proton pump inhibitor for at least 240 days within a 12-month period from 1996 through 2003.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with long-term exposure to pantoprazole and other proton pump inhibitors enrolled in the Northern California Kaiser Permanente health maintenance organization.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Does not applyThis is a non-interventional study, therefore the intervention type / name do not apply.	Other	Pantoprazole
Does not applyThis is a non-interventional study, therefore the intervention type / name do not apply.	Other	Other proton pump inhibitors

Primary outcome

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.

2 secondary outcomes

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 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)

Results and safety

Results posted to the registry on 20 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pantoprazole	34,178	34,178
Other Proton Pump Inhibitors (PPI)	27,686	27,686

Primary outcome: 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). Number (95% Confidence Interval). Unit: incidence per 100000 person-years

Measure	Pantoprazole n = 34178	Other Proton Pump Inhibitors (PPI) n = 27686
Value	19.88 (14.26 to 26.96)	23.73 (12.97 to 39.81)

Pantoprazole vs Other Proton Pump Inhibitors (PPI): Hazard Ratio (HR): 0.68 (95% CI 0.24 to 1.93)

Population analysed: Analysis population included all participants who met the inclusion criteria.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pantoprazole	0 of 0	0 of 0	Not reported
Other Proton Pump Inhibitors (PPI)	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Esophagitis

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Esophagitis, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01322633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.