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Risk of Pancreatic Cancer and Renal Cancer in Patients Exposed to Gabapentin in the United Kingdom General Practice Research Database


N/A
N/A
N/A
Not Enrolling
Both
Renal Pelvis Cancer, Restless Legs Syndrome, Epilepsy, Neuropathic Pain, Chronic Pancreatitis, Hypertension, Pancreatic Cancer, Diabetes, Renal Cancer, Renal Cell Carcinoma

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Trial Information

Risk of Pancreatic Cancer and Renal Cancer in Patients Exposed to Gabapentin in the United Kingdom General Practice Research Database


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 develop a patient cohort. All diagnoses and treatment are recorded in the
course of routine medical practice. Actual number of patients could be less than , as it
is possible for a patient to be represented in more than one of the four arms (See
"Participant Flow: Overall Study" Table) because of the risk set sampling.


Inclusion Criteria:



- 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 Criteria:

- 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.)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Outcome Description:

Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).

Outcome Time Frame:

The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: No Health Authority

Study ID:

114427

NCT ID:

NCT01138124

Start Date:

March 2010

Completion Date:

August 2010

Related Keywords:

  • Renal Pelvis Cancer
  • Restless Legs Syndrome
  • Epilepsy
  • Neuropathic Pain
  • Chronic Pancreatitis
  • Hypertension
  • Pancreatic Cancer
  • Diabetes
  • Renal Cancer
  • Renal Cell Carcinoma
  • renal cell carcinoma
  • epidemiology
  • pancreatic cancer
  • renal cancer
  • renal pelvis cancer
  • GPRD
  • case-control
  • Gapabentin
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Epilepsy
  • Hypertension
  • Neuralgia
  • Pancreatic Neoplasms
  • Pancreatitis
  • Restless Legs Syndrome
  • Pancreatitis, Chronic
  • Pelvic Neoplasms

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