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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01236053
Date of registration:	14/10/2010
Prospective Registration:	No
Primary sponsor:	GlaxoSmithKline
Public title:	Cancer in Patients With Gabapentin (GPRD)
Scientific title:	Risk of Cancer in Patients Exposed to Gabapentin in the GPRD
Date of first enrolment:	June 2010
Target sample size:	2323608
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01236053
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment

Contacts

Name:	GSK Clinical Trials
Address:
Telephone:
Email:
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 subject leaves the GPRD for
any reason including death.

Exclusion Criteria:

- 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.

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

Health Condition(s) or Problem(s) studied

Pain, Neuropathic

Pancreatic Cancer

Renal Cell Carcinoma

Anal Cancer

Breast Cancer

Cancer

Chronic Pancreatitis

Nervous System Cancer

Renal Pelvis Cancer

Epilepsy

Penis Cancer

Bladder Cancer

Diabetes

Stomach Cancer

Bone and Joint Cancer

Renal Cancer

Intervention(s)

Drug: Gabapentin prescriptions

Primary Outcome(s)

Number of All-Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Lung Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Lung Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was same as for case.]

Number of Penile Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Penile Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of Bladder Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of All-Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of All-Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Anal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Anal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of All-Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Breast Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Bladder Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of Breast Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date 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 was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Bladder Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of Breast Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of Lung Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Anal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date 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 was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case]

Number of Penile Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Lung Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Anal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case]

Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was the same as case.]

Number of Breast Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date 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 Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Stomach Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case]

Number of Breast Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date 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 was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Stomach Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of Lung Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Penile Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date 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 Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case]

Number of Renal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date 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 was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Stomach Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of Penile Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Stomach Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [Time Frame: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date 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 was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Stomach Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [Time Frame: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case]

Number of All-Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Anal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [Time Frame: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.]

Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [Time Frame: The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.]

Secondary Outcome(s)

Secondary ID(s)

WEUSRTP4931

114790

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	04/08/2011
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01236053

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