Acid Suppressing Drug Seizure Epidemiology Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01744301
First received: December 5, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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

Condition Intervention
Seizure
Drug: Risk of seizure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 534
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients newly prescribed PPI
All patients newly prescribed PPI
Drug: Risk of seizure
Patients newly prescribed PPI and H2RA, respectively
All patients newly prescribed H2RA
All patients newly prescribed H2RA
Drug: Risk of seizure
Patients newly prescribed PPI and H2RA, respectively

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744301

Locations
Spain
Research Site
Madrid, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Luis a Garcia Rodriguez, MD CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01744301     History of Changes
Other Study ID Numbers: D9612N00017
Study First Received: December 5, 2012
Last Updated: June 17, 2014
Health Authority: Sweden: Medical Product Agency

Keywords provided by AstraZeneca:
Seizure
Acid-suppressing drugs
Epidemiology

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014