Gastroesophageal Reflux Disease (GERD)NCT02555852
Proton Pump Inhibitors and Risk of Community-acquired Pneumonia
An observational study of Gastroesophageal Reflux Disease (GERD) and Community-acquired Pneumonia, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
Trial summary
The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication used to treat gastric conditions, increase the risk of hospitalization for community-acquired pneumonia (HCAP). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Community-acquired Pneumonia
- What is being tested?
- esomeprazole, omeprazole and pantoprazole
- How many people
- 4,238,504 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for an oral NSAID between January 1, 1997 and March 31, 2010. The date of study cohort entry is defined by the prescription date of the newly-prescribed NSAID.
Who may be able to join
- Patients with a first oral NSAID prescription
- Patients at least 40 years of age (except Alberta, Ontario, and Nova Scotia, where patients will be at least 66 years of age)
- Patients with at least 1 year of history in the database.
Who cannot join
- Patients aged < 40 years at cohort entry (or < 66 in Alberta, Ontario, and Nova Scotia)
- Received a prescription for a PPI, a H2RA, or a NSAID (any route of administration) in the 6 months prior to cohort entry
- Had an HCAP (ICD-9-CM code (in any field): 480.x-487.x; ICD-10-CA code: J10.0 - J18.9) or an extended emergency room visit for community-acquired pneumonia in the year prior to cohort entry (where available)
- Hospitalized at the time of cohort entry
- Received a prescription for medications used for the treatment of tuberculosis (ATC Code J04A) (where available)
- Had a history of cancer (other than non-melanoma skin cancer) in the year prior to cohort entry
- Hospitalized >3 days within the 30 days before cohort entry
- Had <1 year of continuous observation time in the database prior to cohort entry
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, H3T1E2
About this study
Official title: Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis
The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication used to treat gastric conditions, increase the risk of hospitalization for community-acquired pneumonia (HCAP).
The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada, the US, and the UK. Cohort entry will be defined by the initiation of an oral non-steroidal anti-inflammatory drug, with follow-up until hospitalization for pneumonia or end of follow-up (6 months). The results from the separate sites will be combined using a statistical approach called meta-analysis to provide an overall assessment of the risk of HCAP with PPIs.
Read the detailed description
Previous observational studies have found an association between proton pump inhibitors (PPIs), a class of medications used to treat gastric conditions, and the risk of community acquired pneumonia. These studies, however, had important limitations including confounding by indication and protopathic bias. The purpose of this study is to determine whether PPIs increase the risk of hospitalization for community-acquired pneumonia (HCAP). To overcome the limitations of previous studies that examined this issue, this study will be conducted in a cohort of new users of non-steroidal anti-inflammatory drugs (NSAIDs), in whom PPIs are often prescribed prophylactically to prevent dyspepsia and other gastric side effects.
The investigators will use a common-protocol approach to conduct retrospective cohort studies using administrative health care data from eight jurisdictions (the Canadian provinces of Alberta, Saskatchewan, Manitoba, Ontario, Quebec, and Nova Scotia, as well as the United States (US) MarketScan, and the United Kingdom (UK) General Practice Research Database [GPRD]). Briefly, the Canadian databases include population-level data on physician billing, diagnoses and procedures from hospital discharge abstracts, and dispensations for prescription drugs. Alberta, Nova Scotia, Ontario, and Quebec data will be restricted to patients aged 65 years and older as prescription data are not available for younger patients. For Quebec, a 10% random sample of eligible patients will be used. The GPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK. US MarketScan includes individuals and their dependents covered by large U.S. employer health insurance plans, and government and public organizations. As Medicare eligibility begins for those above the age of 65, the US MarketScan data will be restricted to patients aged 40 to 65 years in order to ensure complete data capture.
In each jurisdiction, the investigators will assemble a source population that includes all patients with a prescription for an oral NSAID (WHO Anatomical Therapeutic Chemical (ATC) Code M01A). From this source population, a study cohort will be created including all patients who received a prescription for an oral NSAID of ≥ 30 days duration, as patients receiving short duration prescriptions are unlikely to be prescribed a PPI for prophylactic reasons. The date of prescription (for the GPRD) or dispensation (for all other sites) of the oral NSAID will define the date of study cohort entry.
Patients will be followed from the date of study cohort entry until an event (defined below) or censoring due to death, departure from the database, end of follow-up (180 days), or the end of the study period (September 30, 2011 or the last date of data availability at that site), whichever occurs first. Patients will be permitted to enter the cohort multiple times provided that all inclusion criteria are met.
The investigators will create three mutually exclusive exposure categories: 1) PPI users, 2) H2RA users, and 3) unexposed patients. The investigators will use an analysis analogous to an intention-to-treat approach. Exposure to PPIs will be defined as a prescription for a PPI (esomeprazole, omeprazole, pantoprazole, lansoprazole, rabeprazole) on the same day as their cohort entry defining prescription for an NSAID. Exposure to H2RAs will be defined as a prescription for a H2RA (cimetidine, ranitidine, famotidine, nizatidine, niperotidine, roxatidine, ranitidine bismuth citrate, lafutidine, cimetidine combinations, and famotidine combinations) on the same day as their cohort entry defining prescription for an NSAID. Patients that are considered to be unexposed will be defined as patients not prescribed a PPI or H2RA on the same day as their cohort entry defining prescription for an NSAID. The primary outcome will be defined as incident HCAP during the 6 months following initiation of NSAID therapy.
Multiple logistic regression will be used to estimate site-specific adjusted odds ratios (aORs) and corresponding 95% confidence intervals (CIs) for the association of incident HCAP at 6 months and PPI exposure. This is considered the primary analysis. Several sensitivity analyses will be performed to assess the robustness of study results. Such analyses include: restricting analyses to a single, random, observation per patient; excluding patients who received a prescription for a PPI, H2RA, or NSAID in the 12 months before cohort entry; and excluding crossovers between PPI and H2RAs. High dimensional propensity scores will be estimated for all patients in the cohort using logistic regression. Finally, all site-specific estimates will be meta-analyzed using fixed models with inverse variance weighting. The amount of between-site heterogeneity will be estimated using the I-squared statistic.
- Being tested
- esomeprazole, omeprazole, pantoprazole, lansoprazole, rabeprazole
- Keywords
- Proton Pump Inhibitors, Pneumonia, NSAIDs, Histamine H2 Antagonists, Drug safety
- Medical subject headings
- Gastroesophageal Reflux, Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
Also called Proton pump inhibitor
Exposure to esomeprazole (ATC A02BC05, B01AC56, M01AE52, A02BD06) will be defined as a prescription for esomeprazole on the same day as a ≥ 30 day NSAID prescription.
omeprazoleDrug
Also called Proton pump inhibitor
Exposure to omeprazole (ATC A02BC01, A02BD01) will be defined as a prescription for omeprazole on the same day as a ≥ 30 day NSAID prescription.
pantoprazoleDrug
Also called Proton pump inhibitor
Exposure to pantoprazole (ATC A02BC02, A02BD04) will be defined as a prescription for pantoprazole on the same day as a ≥ 30 day NSAID prescription.
lansoprazoleDrug
Also called Proton pump inhibitor
Exposure to lansoprazole (ATC A02BC03, A02BD07, A02BD03, A02BD02) will be defined as a prescription for lansoprazole on the same day as a ≥ 30 day NSAID prescription.
rabeprazoleDrug
Also called Proton pump inhibitor
Exposure to rabeprazole (ATC A02BC04) will be defined as a prescription for rabeprazole on the same day as a ≥ 30 day NSAID prescription.
cimetidineDrug
Also called histamine-2 receptor antagonist
Exposure to cimetidine (ATC A02BA01) will be defined as a prescription for cimetidine on the same day as a ≥ 30 day NSAID prescription.
ranitidineDrug
Also called histamine-2 receptor antagonist
Exposure to ranitidine (A02BA02) will be defined as a prescription for ranitidine on the same day as a ≥ 30 day NSAID prescription.
famotidineDrug
Also called histamine-2 receptor antagonist
Exposure to famotidine (A02BA03) will be defined as a prescription for famotidine on the same day as a ≥30 day NSAID prescription.
nizatidineDrug
Also called histamine-2 receptor antagonist
Exposure to nizatidine (A02BA04) will be defined as a prescription for nizatidine on the same day as a ≥ 30 day NSAID prescription.
niperotidineDrug
Also called histamine-2 receptor antagonist
Exposure to niperotidine (A02BA05) will be defined as a prescription for niperotidine on the same day as a ≥ 30 day NSAID prescription.
roxatidineDrug
Also called histamine-2 receptor antagonist
Exposure to roxatidine (A02BA06) will be defined as a prescription for roxatidine on the same day as a ≥ 30 day NSAID prescription.
ranitidine bismuth citrateDrug
Also called histamine-2 receptor antagonist
Exposure to ranitidine bismuth citrate (A02BA07) will be defined as a prescription for ranitidine bismuth citrate on the same day as a ≥ 30 day NSAID prescription.
lafutidineDrug
Also called histamine-2 receptor antagonist
Exposure to lafutidine (A02BA08) will be defined as a prescription for lafutidine on the same day as a ≥ 30 day NSAID prescription.
cimetidine combinationsDrug
Also called histamine-2 receptor antagonist
Exposure to cimetidine combinations (A02BA51) will be defined as a prescription for cimetidine combinations on the same day as a ≥ 30 day NSAID prescription.
famotidine combinationsDrug
Also called histamine-2 receptor antagonist
Exposure to famotidine combinations (A02BA53) will be defined as a prescription for famotidine combinations on the same day as a ≥ 30 day NSAID prescription.
| Study group | Role | What they receive |
|---|---|---|
| Users of PPIs | Exposure to proton pump inhibitors (PPIs) will be defined as a prescription for a PPI (esomeprazole, omeprazole, pantoprazole, lansoprazole, rabeprazole, and combinations) on the same day as the cohort entry defining prescription for an NSAID. Receives: Drug: esomeprazole; Drug: omeprazole; Drug: pantoprazole; Drug: lansoprazole; Drug: rabeprazole | |
| Users of H2RAs | Exposure to histamine-2 receptor antagonists (H2RAs) will be defined as a prescription for a H2RA (cimetidine, ranitidine, famotidine, nizatidine, niperotidine, roxatidine, ranitidine bismuth citrate, lafutidine, cimetidine combinations, and famotidine combinations) on the same day as the cohort entry defining prescription for an NSAID. Receives: Drug: cimetidine; Drug: ranitidine; Drug: famotidine; Drug: nizatidine; Drug: niperotidine; Drug: roxatidine; Drug: ranitidine bismuth citrate; Drug: lafutidine; Drug: cimetidine combinations; Drug: famotidine combinations | |
| Unexposed group (Reference) | Patients that are considered to be unexposed will be defined as patients not prescribed a PPI or H2RA on the same day as the cohort entry defining prescription for an NSAID. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for Community-Acquired Pneumonia (HCAP)
HCAP during the 6 months following cohort entry
Patients with HCAP with any of the following diagnostic codes: ICD-9: 487.0, 487.1, 487.0, 487.1, 487.0, 480.9, 481.x, 482.2, 482.0, 482.1, 482.30, 482.31, 482.32, 482.39, 482.40, 482.41, 482.42, 482.49, 482.81, 482.82, 482.83, 482.89, 482.9, 483.0, 484.7, 484.8, 485.X, 481.X, 486.X ; ICD-10: J10.0, J11.0, J11.1, J12.9, J13, J14, J15.X, J16.8, J17.0, J17.2, J17.3, J17.8, J18.0, J18.1, J18.8, J18.9.
Measured: Patients will be followed from the date of study cohort entry until HCAP, censoring, or for up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 4,238,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Kristian Filion, PhD, Principal investigator, Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555852
- Sponsor's protocol ID
- CNODES_DEMO-2
- Status last verified
- Sep 2015
- First submitted
- 18 Sep 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Filion KB, Chateau D, Targownik LE, Gershon A, Durand M, Tamim H, Teare GF, Ravani P, Ernst P, Dormuth CR; CNODES Investigators. Proton pump inhibitors and the risk of hospitalisation for community-acquired pneumonia: replicated cohort studies with meta-analysis. Gut. 2014 Apr;63(4):552-8. doi: 10.1136/gutjnl-2013-304738. Epub 2013 Jul 15.
PubMed 23856153
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis
- ClinicalTrials.gov ID
- NCT02555852
- Acronym / sponsor ID
- CNODES_DEMO-2
- Keywords
- Proton Pump Inhibitors, Pneumonia, NSAIDs, Histamine H2 Antagonists, Drug safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,238,504 participants (actual)
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODESUniversity, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication used to treat gastric conditions, increase the risk of hospitalization for community-acquired pneumonia (HCAP).
The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada, the US, and the UK. Cohort entry will be defined by the initiation of an oral non-steroidal anti-inflammatory drug, with follow-up until hospitalization for pneumonia or end of follow-up (6 months). The results from the separate sites will be combined using a statistical approach called meta-analysis to provide an overall assessment of the risk of HCAP with PPIs.
Detailed description
Previous observational studies have found an association between proton pump inhibitors (PPIs), a class of medications used to treat gastric conditions, and the risk of community acquired pneumonia. These studies, however, had important limitations including confounding by indication and protopathic bias. The purpose of this study is to determine whether PPIs increase the risk of hospitalization for community-acquired pneumonia (HCAP). To overcome the limitations of previous studies that examined this issue, this study will be conducted in a cohort of new users of non-steroidal anti-inflammatory drugs (NSAIDs), in whom PPIs are often prescribed prophylactically to prevent dyspepsia and other gastric side effects.
The investigators will use a common-protocol approach to conduct retrospective cohort studies using administrative health care data from eight jurisdictions (the Canadian provinces of Alberta, Saskatchewan, Manitoba, Ontario, Quebec, and Nova Scotia, as well as the United States (US) MarketScan, and the United Kingdom (UK) General Practice Research Database [GPRD]). Briefly, the Canadian databases include population-level data on physician billing, diagnoses and procedures from hospital discharge abstracts, and dispensations for prescription drugs. Alberta, Nova Scotia, Ontario, and Quebec data will be restricted to patients aged 65 years and older as prescription data are not available for younger patients. For Quebec, a 10% random sample of eligible patients will be used. The GPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK. US MarketScan includes individuals and their dependents covered by large U.S. employer health insurance plans, and government and public organizations. As Medicare eligibility begins for those above the age of 65, the US MarketScan data will be restricted to patients aged 40 to 65 years in order to ensure complete data capture.
In each jurisdiction, the investigators will assemble a source population that includes all patients with a prescription for an oral NSAID (WHO Anatomical Therapeutic Chemical (ATC) Code M01A). From this source population, a study cohort will be created including all patients who received a prescription for an oral NSAID of ≥ 30 days duration, as patients receiving short duration prescriptions are unlikely to be prescribed a PPI for prophylactic reasons. The date of prescription (for the GPRD) or dispensation (for all other sites) of the oral NSAID will define the date of study cohort entry.
Patients will be followed from the date of study cohort entry until an event (defined below) or censoring due to death, departure from the database, end of follow-up (180 days), or the end of the study period (September 30, 2011 or the last date of data availability at that site), whichever occurs first. Patients will be permitted to enter the cohort multiple times provided that all inclusion criteria are met.
The investigators will create three mutually exclusive exposure categories: 1) PPI users, 2) H2RA users, and 3) unexposed patients. The investigators will use an analysis analogous to an intention-to-treat approach. Exposure to PPIs will be defined as a prescription for a PPI (esomeprazole, omeprazole, pantoprazole, lansoprazole, rabeprazole) on the same day as their cohort entry defining prescription for an NSAID. Exposure to H2RAs will be defined as a prescription for a H2RA (cimetidine, ranitidine, famotidine, nizatidine, niperotidine, roxatidine, ranitidine bismuth citrate, lafutidine, cimetidine combinations, and famotidine combinations) on the same day as their cohort entry defining prescription for an NSAID. Patients that are considered to be unexposed will be defined as patients not prescribed a PPI or H2RA on the same day as their cohort entry defining prescription for an NSAID. The primary outcome will be defined as incident HCAP during the 6 months following initiation of NSAID therapy.
Multiple logistic regression will be used to estimate site-specific adjusted odds ratios (aORs) and corresponding 95% confidence intervals (CIs) for the association of incident HCAP at 6 months and PPI exposure. This is considered the primary analysis. Several sensitivity analyses will be performed to assess the robustness of study results. Such analyses include: restricting analyses to a single, random, observation per patient; excluding patients who received a prescription for a PPI, H2RA, or NSAID in the 12 months before cohort entry; and excluding crossovers between PPI and H2RAs. High dimensional propensity scores will be estimated for all patients in the cohort using logistic regression. Finally, all site-specific estimates will be meta-analyzed using fixed models with inverse variance weighting. The amount of between-site heterogeneity will be estimated using the I-squared statistic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Users of PPIs | – | Drug: esomeprazole, Drug: omeprazole, Drug: pantoprazole, Drug: lansoprazole, Drug: rabeprazoleExposure to proton pump inhibitors (PPIs) will be defined as a prescription for a PPI (esomeprazole, omeprazole, pantoprazole, lansoprazole, rabeprazole, and combinations) on the same day as the cohort entry defining prescription for an NSAID. |
| Users of H2RAs | – | Drug: cimetidine, Drug: ranitidine, Drug: famotidine, Drug: nizatidine, Drug: niperotidine, Drug: roxatidine, Drug: ranitidine bismuth citrate, Drug: lafutidine, Drug: cimetidine combinations, Drug: famotidine combinationsExposure to histamine-2 receptor antagonists (H2RAs) will be defined as a prescription for a H2RA (cimetidine, ranitidine, famotidine, nizatidine, niperotidine, roxatidine, ranitidine bismuth citrate, lafutidine, cimetidine combinations, and famotidine combinations) on the same day as the cohort entry defining prescription for an NSAID. |
| Unexposed group (Reference) | – | –Patients that are considered to be unexposed will be defined as patients not prescribed a PPI or H2RA on the same day as the cohort entry defining prescription for an NSAID. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for an oral NSAID between January 1, 1997 and March 31, 2010. The date of study cohort entry is defined by the prescription date of the newly-prescribed NSAID.
Key inclusion criteria (3 listed)
- Patients with a first oral NSAID prescription
- Patients at least 40 years of age (except Alberta, Ontario, and Nova Scotia, where patients will be at least 66 years of age)
- Patients with at least 1 year of history in the database.
Key exclusion criteria (8 listed)
- Patients aged < 40 years at cohort entry (or < 66 in Alberta, Ontario, and Nova Scotia)
- Received a prescription for a PPI, a H2RA, or a NSAID (any route of administration) in the 6 months prior to cohort entry
- Had an HCAP (ICD-9-CM code (in any field): 480.x-487.x; ICD-10-CA code: J10.0 - J18.9) or an extended emergency room visit for community-acquired pneumonia in the year prior to cohort entry (where available)
- Hospitalized at the time of cohort entry
- Received a prescription for medications used for the treatment of tuberculosis (ATC Code J04A) (where available)
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 |
|---|---|---|
| esomeprazoleAlso: Proton pump inhibitorExposure to esomeprazole (ATC A02BC05, B01AC56, M01AE52, A02BD06) will be defined as a prescription for esomeprazole on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of PPIs |
| omeprazoleAlso: Proton pump inhibitorExposure to omeprazole (ATC A02BC01, A02BD01) will be defined as a prescription for omeprazole on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of PPIs |
| pantoprazoleAlso: Proton pump inhibitorExposure to pantoprazole (ATC A02BC02, A02BD04) will be defined as a prescription for pantoprazole on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of PPIs |
| lansoprazoleAlso: Proton pump inhibitorExposure to lansoprazole (ATC A02BC03, A02BD07, A02BD03, A02BD02) will be defined as a prescription for lansoprazole on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of PPIs |
| rabeprazoleAlso: Proton pump inhibitorExposure to rabeprazole (ATC A02BC04) will be defined as a prescription for rabeprazole on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of PPIs |
| cimetidineAlso: histamine-2 receptor antagonistExposure to cimetidine (ATC A02BA01) will be defined as a prescription for cimetidine on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
| ranitidineAlso: histamine-2 receptor antagonistExposure to ranitidine (A02BA02) will be defined as a prescription for ranitidine on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
| famotidineAlso: histamine-2 receptor antagonistExposure to famotidine (A02BA03) will be defined as a prescription for famotidine on the same day as a ≥30 day NSAID prescription. | Drug | Users of H2RAs |
| nizatidineAlso: histamine-2 receptor antagonistExposure to nizatidine (A02BA04) will be defined as a prescription for nizatidine on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
| niperotidineAlso: histamine-2 receptor antagonistExposure to niperotidine (A02BA05) will be defined as a prescription for niperotidine on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
| roxatidineAlso: histamine-2 receptor antagonistExposure to roxatidine (A02BA06) will be defined as a prescription for roxatidine on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
| ranitidine bismuth citrateAlso: histamine-2 receptor antagonistExposure to ranitidine bismuth citrate (A02BA07) will be defined as a prescription for ranitidine bismuth citrate on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
| lafutidineAlso: histamine-2 receptor antagonistExposure to lafutidine (A02BA08) will be defined as a prescription for lafutidine on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
| cimetidine combinationsAlso: histamine-2 receptor antagonistExposure to cimetidine combinations (A02BA51) will be defined as a prescription for cimetidine combinations on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
| famotidine combinationsAlso: histamine-2 receptor antagonistExposure to famotidine combinations (A02BA53) will be defined as a prescription for famotidine combinations on the same day as a ≥ 30 day NSAID prescription. | Drug | Users of H2RAs |
Primary outcome
Hospitalization for Community-Acquired Pneumonia (HCAP)
Time frame: Patients will be followed from the date of study cohort entry until HCAP, censoring, or for up to 6 months.
HCAP during the 6 months following cohort entry Patients with HCAP with any of the following diagnostic codes: ICD-9: 487.0, 487.1, 487.0, 487.1, 487.0, 480.9, 481.x, 482.2, 482.0, 482.1, 482.30, 482.31, 482.32, 482.39, 482.40, 482.41, 482.42, 482.49, 482.81, 482.82, 482.83, 482.89, 482.9, 483.0, 484.7, 484.8, 485.X, 481.X, 486.X ; ICD-10: J10.0, J11.0, J11.1, J12.9, J13, J14, J15.X, J16.8, J17.0, J17.2, J17.3, J17.8, J18.0, J18.1, J18.8, J18.9.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
- Results publication: PubMed 23856153Filion KB, Chateau D, Targownik LE, Gershon A, Durand M, Tamim H, Teare GF, Ravani P, Ernst P, Dormuth CR; CNODES Investigators. Proton pump inhibitors and the risk of hospitalisation for community-acquired pneumonia: replicated cohort studies with meta-analysis. Gut. 2014 Apr;63(4):552-8. doi: 10.1136/gutjnl-2013-304738. Epub 2013 Jul 15.
- This organization's website describing general functions, other CNODES projects, and investigator profiles.Link provided by the sponsor.
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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.
Kristian Filion, PhD principal investigator
Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD) and Community-acquired Pneumonia, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
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 3 inclusion and 8 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 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospitalization for Community-Acquired Pneumonia (HCAP) (time frame: Patients will be followed from the date of study cohort entry until HCAP, censoring, or for up to 6 months.). 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 NCT02555852, which also lists 1 linked publication.
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 22 Sep 2015.