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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01138124
• Date of registration: 03/06/2010
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)
• Scientific title: Risk of Pancreatic Cancer and Renal Cancer in Patients Exposed to Gabapentin in the United Kingdom General Practice Research Database
• Date of first enrolment: March 2010
• Target sample size: 54202
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01138124
• Study type: Observational
• Phase: N/A

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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.)



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Hypertension

Renal Cancer

Epilepsy

Renal Pelvis Cancer

Neuropathic Pain

Chronic Pancreatitis

Restless Legs Syndrome

Pancreatic Cancer

Renal Cell Carcinoma

Intervention(s)

Drug: Gabapentin prescriptions

Primary Outcome(s)

Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [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]

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

Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date (ID) was the date of incident renal 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.]

Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date (ID) was the date of incident renal 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.]

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

Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date (ID) was the date of incident renal 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.]

Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [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]

Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date (ID) was the date of incident renal 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.]

Secondary ID(s)

WEUSKOP4774

114427

EPI40634

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/01/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01138124