Acid Suppressing Drug Seizure Epidemiology Study

NCT01744301 | Completed

• 1 other identifier: D9612N00017
• Study Type: observational
• Target: 8,605
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is

1. 1.to estimate the incidence of seizure in the general population and stratified by epilepsy status
2. 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

Conditions

Seizure

Keywords

Seizure; Acid-suppressing drugs; Epidemiology

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

All patients newly prescribed PPI

All patients newly prescribed PPI

Drug: Risk of seizure

All patients newly prescribed H2RA

All patients newly prescribed H2RA

Drug: Risk of seizure

Interventions

Risk of seizure DRUG

Patients newly prescribed PPI and H2RA, respectively

All patients newly prescribed H2RA; All patients newly prescribed PPI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Madrid, Spain

Location

Related Publications (1)

• Saez ME, Gonzalez-Perez A, Gaist D, Johansson S, Nagy P, Garcia Rodriguez 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.

  PMID: 27450309 BACKGROUND

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis a Garcia Rodriguez, MD

  CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 6, 2012
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 9, 2016

Record last verified: 2015-12

Locations

ES (1)