Acid suppressing Drug Seizure Epidemiology Study

Study identifier:D9612N00017

ClinicalTrials.gov identifier:NCT01744301

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Seizure

Phase

N/A

Healthy volunteers

Study drug

Risk of seizure

Sex

All

Actual Enrollment

8605

Study type

Observational

Age

N/A

Date

Study Start Date: 01 Mar 2013

Primary Completion Date: 01 Dec 2014

Study Completion Date: 01 Dec 2014

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Sept 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	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

Documents available

D9612N00017_Redacted_protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Saga Johansson

46317761526

[email protected]

Investigators

Principal Investigator

Luis a Garcia Rodriguez

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