SeizureNCT01744301
Acid Suppressing Drug Seizure Epidemiology Study
An observational study of Seizure, run by AstraZeneca at 1 site in Spain.
Trial summary
The purpose of this study is 1. to estimate the incidence of seizure in the general population and stratified by epilepsy status 2. To estimate the relative risk of seizure associated with use of proton pump inhibitors and histamine 2 receptor antagonist and stratified by epilepsy status Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Seizure
- What is being tested?
- Risk of seizure
- How many people
- 8,605 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals aged 20-84 years from 1 January 2005 to 31 December 2011, who have been enrolled with their primary care physician for at least 2 years and have a computerized prescription history of at least 1 year. Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year, and never have a diagnosis of cancer, alcohol abuse or alcohol-related disease, or drug abuse.
Who may be able to join
- Primary care physician for at least 2 years.
- Computerized prescription history of at least 1 year.
- Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year.
- No diagnosis of cancer.
- No alcohol abuse or alcohol-related disease- No drug abuse.
Who cannot join
- Patients with at least 1 prescription of PPI or H2RA in the year prior to start date.
- Cancer before start date.
- Alcohol abuse or alcohol-related disease before start date.
- Drug abuse before start date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Study With a Nested Case Control Analysis on the Association Between Acid-suppressing Drugs and Seizures Using THIN Database in the UK
The purpose of this study is
- to estimate the incidence of seizure in the general population and stratified by epilepsy status
- To estimate the relative risk of seizure associated with use of proton pump inhibitors and histamine 2 receptor antagonist and stratified by epilepsy status
Read the detailed description
A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK
- Conditions
- Seizure
- Being tested
- Risk of seizure
- Keywords
- Seizure, Acid-suppressing drugs, Epidemiology
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk of seizureDrug
Patients newly prescribed PPI and H2RA, respectively
| Study group | Role | What they receive |
|---|---|---|
| All patients newly prescribed PPI | All patients newly prescribed PPI Receives: Drug: Risk of seizure | |
| All patients newly prescribed H2RA | All patients newly prescribed H2RA Receives: Drug: Risk of seizure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of seizure in the general population and stratified by epilepsy status.
Measured: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.
Follow-up of safety outcomes: First recorded entry of seizure.
Measured: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2014
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 SeizureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Retrospective
- Enrolment
- 8,605 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis a Garcia Rodriguez, MD, Principal investigator, CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744301
- Sponsor's protocol ID
- D9612N00017
- Status last verified
- Dec 2015
- First submitted
- 5 Dec 2012
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Saez ME, Gonzalez-Perez A, Gaist D, Johansson S, Nagy P, Garcia Rodriguez LA. Risk of seizure associated with use of acid-suppressive drugs: An observational cohort study. Epilepsy Behav. 2016 Sep;62:72-80. doi: 10.1016/j.yebeh.2016.06.039. Epub 2016 Jul 21.
PubMed 27450309
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study With a Nested Case Control Analysis on the Association Between Acid-suppressing Drugs and Seizures Using THIN Database in the UK
- ClinicalTrials.gov ID
- NCT01744301
- Acronym / sponsor ID
- D9612N00017
- Conditions
- Seizure
- Keywords
- Seizure, Acid-suppressing drugs, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,605 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Dec 2012 (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 this study is
- to estimate the incidence of seizure in the general population and stratified by epilepsy status
- To estimate the relative risk of seizure associated with use of proton pump inhibitors and histamine 2 receptor antagonist and stratified by epilepsy status
Detailed description
A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All patients newly prescribed PPI | – | Drug: Risk of seizureAll patients newly prescribed PPI |
| All patients newly prescribed H2RA | – | Drug: Risk of seizureAll patients newly prescribed H2RA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals aged 20-84 years from 1 January 2005 to 31 December 2011, who have been enrolled with their primary care physician for at least 2 years and have a computerized prescription history of at least 1 year. Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year, and never have a diagnosis of cancer, alcohol abuse or alcohol-related disease, or drug abuse.
Key inclusion criteria (5 listed)
- Primary care physician for at least 2 years.
- Computerized prescription history of at least 1 year.
- Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year.
- No diagnosis of cancer.
- No alcohol abuse or alcohol-related disease- No drug abuse.
Key exclusion criteria (4 listed)
- Patients with at least 1 prescription of PPI or H2RA in the year prior to start date.
- Cancer before start date.
- Alcohol abuse or alcohol-related disease before start date.
- Drug abuse before start date.
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 |
|---|---|---|
| Risk of seizurePatients newly prescribed PPI and H2RA, respectively | Drug | All patients newly prescribed H2RA, All patients newly prescribed PPI |
Primary outcome
Incidence of seizure in the general population and stratified by epilepsy status.
Time frame: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.
Follow-up of safety outcomes: First recorded entry of seizure.
Time frame: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.
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 9 Sep 2016.
- Background: PubMed 27450309Saez ME, Gonzalez-Perez A, Gaist D, Johansson S, Nagy P, Garcia Rodriguez LA. Risk of seizure associated with use of acid-suppressive drugs: An observational cohort study. Epilepsy Behav. 2016 Sep;62:72-80. doi: 10.1016/j.yebeh.2016.06.039. Epub 2016 Jul 21.
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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.
Luis a Garcia Rodriguez, MD principal investigator
CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
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 Seizure, run by AstraZeneca at 1 site in Spain.
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 5 inclusion and 4 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 9 Sep 2016. 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 Spain. 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?
Incidence of seizure in the general population and stratified by epilepsy status. (time frame: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.). The study lists 2 primary outcomes in all. 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 NCT01744301, 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 9 Sep 2016.