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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 
Overall Participants Analyzed 
[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 
[1] Number of participants with the indicated age at index date.
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 [1] 
[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 
[1] 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).
Number of participants with the indicated body mass index (BMI) [1] 
[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 
[1] 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).
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 [1] 
[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 
[1] Medical conditions up to the index date by READ/OXMIS codes were analyzed.
Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls [1] 
[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] 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



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