Acid Suppressing Drug Seizure Epidemiology Study

Completed

• Conditions: Seizure
• Interventions: Drug: Risk of seizure

• Registration Number: NCT01744301
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Study Start: 2013-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-12
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8605

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients newly prescribed H2RA	Risk of seizure	All patients newly prescribed H2RA
All patients newly prescribed PPI	Risk of seizure	All patients newly prescribed PPI

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain