Status:
COMPLETED
Cancer in Patients With Gabapentin (GPRD)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pain, Neuropathic
Epilepsy
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
Actual number of patients may be less, as it is possible for a patient to be represented in more than one of the 22 arms (See "Participant Flow: Overall Study" Table) because of the risk set sampling.
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 subject leaves the GPRD for any reason including death.
Exclusion
- Subjects are excluded from the GPRD cohort if they have a cancer diagnosis or a history of cancer prior to the cohort entry date. 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.) Cases must have no history of any other cancer diagnosis prior to the index date. Controls are required to be free of cancer diagnosis in the database up to the control's index date.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
2323608 Patients enrolled
Trial Details
Trial ID
NCT01236053
Start Date
June 1 2010
End Date
September 1 2010
Last Update
July 6 2017
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