Status: Finalised First registered on: 23/02/2017
Last updated on: 11/04/2017
1. Study identification
EU PAS Register NumberEUPAS17954
Official titleA cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK
Study title acronymAcid suppressing Drug Seizure Epidemiology Study
Study typeObservational study
Brief description of the studyIn this observational study (NCT01744301), patients aged 20–84 years in 2005–2011 were identified from The Health Improvement Network. The relative risk of seizure associated with use of proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) in a general population was quantified, overall and stratified by epilepsy status, and the effects of demographics and comorbidities were determined. In a nested case–control analysis, seizure cases were matched to controls. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using unconditional logistic regression. Estimates were adjusted for potential confounders.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD9612N00017
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCEIFE
Department/Research groupFundación Centro Español de Investigación Farmacoepidemiológica
Organisation/affiliationFundación CEIFE
Website/Homepagewww.ceife.es
Details of (Primary) lead investigator
Title Dr
Last name García Rodríguez
First name Luis Alberto
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/12/2011
Start date of data collection22/03/2013
Start date of data analysis21/12/2014
Date of interim report, if expected
Date of final study report15/05/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name García Rodríguez
First name Luis Alberto
Address line 11800 Concord Pike
Address line 2PO Box 15437 
Address line 3 
CityWilmington 
Postcode19850 
CountryUnited States
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com
Public Enquiries
Title Dr 
Last name AstraZeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike 
Address line 2PO Box 15437 
Address line 3 
CityWilmington 
Postcode19850 
CountryUnited States 
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com 
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