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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01138124
First received: June 3, 2010
Last updated: June 23, 2011
Last verified: June 2011
Results First Received: December 16, 2010  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Retrospective
Conditions: Renal Pelvis Cancer
Restless Legs Syndrome
Epilepsy
Neuropathic Pain
Chronic Pancreatitis
Hypertension
Pancreatic Cancer
Diabetes
Renal Cancer
Renal Cell Carcinoma
Intervention: Drug: Gabapentin prescriptions

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 anonymized and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Actual number of patients may be less, 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.

Reporting Groups
  Description
Pancreatic Cancer Cases Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
Pancreatic Cancer Controls

Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site.

The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.

Renal Cancer Cases Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
Renal Cancer Controls Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.

Participant Flow:   Overall Study
    Pancreatic Cancer Cases     Pancreatic Cancer Controls     Renal Cancer Cases     Renal Cancer Controls  
STARTED     3149     30026     1981     19046  
COMPLETED     3149     30026     1981     19046  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pancreatic Cancer Cases Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
Pancreatic Cancer Controls Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
Renal Cancer Cases Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
Renal Cancer Controls Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
Total Total of all reporting groups

Baseline Measures
    Pancreatic Cancer Cases     Pancreatic Cancer Controls     Renal Cancer Cases     Renal Cancer Controls     Total  
Number of Participants  
[units: participants]
  3149     30026     1981     19046     54202  
Age, Customized [1]
[units: Participants]
         
<40 years     18     199     43     446     706  
40-49 years     86     897     134     1348     2465  
50-59 years     367     3616     355     3418     7756  
60-69 years     748     7234     528     5199     13709  
70-79 years     1033     10092     594     5604     17323  
>=80 years     897     7988     327     3031     12243  
Gender  
[units: Participants]
         
Female     1603     15316     759     7273     24951  
Male     1546     14710     1222     11773     29251  
Number of participants with the indicated duration of follow-up from GPRD registration to index date  
[units: participants]
         
2-3 years     173     1460     129     1081     2843  
4-5 years     185     1509     117     1135     2946  
6-7 years     237     2007     141     1280     3665  
>=8 years     2554     25050     1594     15550     44748  
Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID [2]
[units: participants]
         
2-3 years     446     4121     286     2653     7506  
4-5 years     396     3656     226     2122     6400  
6-7 years     447     4213     246     2338     7244  
>=8 years     1860     18036     1223     11933     33052  
Number of participants with the indicated body mass index (BMI) [3]
[units: participants]
         
<18.5 kg/m^2     25     203     18     110     356  
18.5 to 24.99 kg/m^2     459     3678     237     2236     6610  
25 to 29.99 kg/m^2     457     4250     326     2938     7971  
>=30 kg/m^2     291     2476     250     1773     4790  
Missing     1917     19419     1150     11989     34475  
Number of participants with the indicated smoking status  
[units: participants]
         
Current Smoker     731     4857     476     3555     9619  
Ex-smoker     768     6626     524     4589     12507  
Never Smoked     1385     15249     867     9121     26622  
Status Unknown     265     3294     114     1781     5454  
Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls [4]
[units: participants]
         
Diabetes (>=2 years prior to index date [ID])     363     2137     0     0     2500  
Epilepsy     53     458     0     0     511  
Neuropathic Pain     737     6616     0     0     7353  
Chronic Pancreatitis (>=2 years prior to ID)     13     17     0     0     30  
Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls [5]
[units: participants]
         
Hypertension     0     0     1159     9113     10272  
Diuretic use     0     0     875     6396     7271  
Diabetes     0     0     240     1598     1838  
Epilepsy     0     0     33     303     336  
Neuropathic Pain     0     0     428     4018     4446  
[1] Number of participants with the indicated age at index date.
[2] Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date (ID).
[3] BMI is calculated as weight in kilograms (between one and three years prior to the index date, closest to 1 year prior to index date) divided by height in meters (one year or longer prior to index date) squared (m^2).
[4] Medical conditions up to the index date by READ/OXMIS codes were analyzed.
[5] Medical conditions up to the index date by READ/OXMIS codes were analyzed. Drug use up to the index date according to British National Formulary codes was analyzed.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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 ]

5.  Primary:   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. ]

6.  Primary:   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. ]

7.  Primary:   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. ]

8.  Primary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01138124     History of Changes
Other Study ID Numbers: 114427, EPI40634, WEUSKOP4774
Study First Received: June 3, 2010
Results First Received: December 16, 2010
Last Updated: June 23, 2011
Health Authority: United States: No Health Authority