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Acid Suppressing Drug Seizure Epidemiology Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744301
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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

Condition or disease Intervention/treatment
Seizure Drug: Risk of seizure

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

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Study Type : Observational
Actual Enrollment : 8605 participants
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
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744301


Locations
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Spain
Research Site
Madrid, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Luis a Garcia Rodriguez, MD CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: CSR Study Report Synopsis
D9612N00017_Seizure_Study_report_synopsis_FINAL_redacted

Publications:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01744301    
Other Study ID Numbers: D9612N00017
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: December 2015
Keywords provided by AstraZeneca:
Seizure
Acid-suppressing drugs
Epidemiology
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases