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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01744301
Enrollment
8605
Registered
2012-12-06
Start date
2013-03-31
Completion date
2014-12-31
Last updated
2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizure

Keywords

Seizure, Acid-suppressing drugs, Epidemiology

Brief 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

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

Interventions

DRUGRisk of seizure

Patients newly prescribed PPI and H2RA, respectively

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of seizure in the general population and stratified by epilepsy status.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.Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026