Skip to main content
OpenTrials
Completed

NCT Number: NCT01744301

Acid Suppressing Drug Seizure Epidemiology Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Seizure Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Madrid, Spain

About this 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risk of seizure

Drug

Patients newly prescribed PPI and H2RA, respectively

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Cohort Study With a Nested Case Control Analysis on the Association Between Acid-suppressing Drugs and Seizures Using THIN Database in the UK

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2012
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.