Acid Suppressing Drug Seizure Epidemiology Study

Seizure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744301
• Other study ID #: D9612N00017
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: September 8, 2016
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Product Agency
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8605
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Seizure
• Seizures

Intervention

Drug:
• Risk of seizure
Patients newly prescribed PPI and H2RA, respectively

Locations

Country	Name	City	State
Spain	Research Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Sáez ME, González-Pérez A, Gaist D, Johansson S, Nagy P, García Rodríguez LA. Risk of seizure associated with use of acid-suppressive drugs: An observational cohort study. Epilepsy Behav. 2016 Sep;62:72-80. doi: 10.1016/j.yebeh.2016.06.039. Epub 2016 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	Yes