Acid Suppressing Drug Seizure Epidemiology Study
This study is currently recruiting participants.
Verified May 2013 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01744301
First received: December 5, 2012
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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
| Condition |
|---|
|
Seizure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300000 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
All patients newly prescribed PPI
All patients newly prescribed PPI
|
|
All patients newly prescribed H2RA
All patients newly prescribed H2RA
|
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
Eligibility| Ages Eligible for Study: | 20 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744301
Contacts
| Contact: AstraZeneca Clinical Study Information | 8002369933 | information.center@astrazeneca.com |
| Contact: Saga Johansson | 46317761526 | saga.johansson@astrazeneca.com |
Locations
| Spain | |
| Research Site | Recruiting |
| Madrid, Spain | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Luis a Garcia Rodriguez, MD | CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research ) |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01744301 History of Changes |
| Other Study ID Numbers: | D9612N00017 |
| Study First Received: | December 5, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Sweden: Medical Product Agency |
Keywords provided by AstraZeneca:
|
Seizure Acid-suppressing drugs Epidemiology |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013