Status:

COMPLETED

Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)

Lead Sponsor:

GlaxoSmithKline

Conditions:

Renal Pelvis Cancer

Restless Legs Syndrome

Eligibility:

All Genders

Brief Summary

High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous re...

Detailed Description

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develo...

Eligibility Criteria

Inclusion

  • The study cohort from which cases and controls are drawn is all subjects in the UK GPRD 1993-2008. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993. Follow-up ends Dec 31, 2008, or earlier if the respective cancer is diagnosed, or if the subject leaves the GPRD for any reason including death.

Exclusion

  • Cases and controls will be required to have at least 2 years of follow-up in the study cohort before their index date (For cases, the index date is the date of first diagnosis of the respective cancer. The index date for controls is set as the date at which the follow-up time from cohort entry is the same as the case.)

Key Trial Info

Start Date :

March 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2010

Estimated Enrollment :

54202 Patients enrolled

Trial Details

Trial ID

NCT01138124

Start Date

March 1 2010

End Date

August 1 2010

Last Update

May 30 2017

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