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Acid Suppressing Drug Seizure Epidemiology Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01744301
First received: December 5, 2012
Last updated: November 4, 2014
Last verified: November 2014

December 5, 2012
November 4, 2014
March 2013
December 2014   (final data collection date for 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. ] [ 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 ]
  • Incidence of seizure in the general population and stratified by epilepsy status. [ Time Frame: Study period 1 Jan 2005 -31 December 2011 ] [ Designated as safety issue: No ]
  • Follow-up of safety outcomes: First recorded entry of seizure. [ Time Frame: Study period 1 Jan 2005 -31 December 2011 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01744301 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Acid Suppressing Drug Seizure Epidemiology Study
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

  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

A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

Seizure
Drug: Risk of seizure
Patients newly prescribed PPI and H2RA, respectively
  • All patients newly prescribed PPI
    All patients newly prescribed PPI
    Intervention: Drug: Risk of seizure
  • All patients newly prescribed H2RA
    All patients newly prescribed H2RA
    Intervention: Drug: Risk of seizure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8500
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01744301
D9612N00017
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Luis a Garcia Rodriguez, MD CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
AstraZeneca
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP