Acid Suppressing Drug Seizure Epidemiology Study

September 8, 2016 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8605

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients newly prescribed PPI
Drug: Risk of seizure
Patients newly prescribed PPI and H2RA, respectively
All patients newly prescribed H2RA
Drug: Risk of seizure
Patients newly prescribed PPI and H2RA, respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (ESTIMATE)

December 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9612N00017

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol
    Information identifier: CSR Study Report Synopsis
    Information comments: D9612N00017_Seizure_Study_report_synopsis_FINAL_redacted

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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