A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00785772
First received: November 3, 2008
Last updated: October 31, 2011
Last verified: October 2011
Results First Received: March 29, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Impairment
Intervention: Drug: Gabapentin

  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
Study Initiation Date and Completion Dates: 16 March 2010 to 1 April 2010 Study Center: 1 center in Japan

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A subject who had already been taking gabapentin was enrolled in the study.

Reporting Groups
  Description
Gabapentin

The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.


Participant Flow:   Overall Study
    Gabapentin  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     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
Gabapentin

The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.


Baseline Measures
    Gabapentin  
Number of Participants  
[units: participants]
  1  
Age, Customized  
[units: Participant]
 
<=19 years     0  
20-64 years     1  
>=65 years     0  
Gender  
[units: Participant]
 
Female     0  
Male     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Observed Plasma Gabapentin Concentration   [ Time Frame: Days 8 and 15 ]

2.  Primary:   Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model   [ Time Frame: Days 8 and 15 ]

3.  Primary:   Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration   [ Time Frame: Days 8 and 15 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
The study was completed with an enrollment of 1 subject because prolongation of the study period or a change in the inclusion criteria (the upper limit of age was deleted) did not lead to further enrollment of subjects.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00785772     History of Changes
Other Study ID Numbers: A9451169
Study First Received: November 3, 2008
Results First Received: March 29, 2011
Last Updated: October 31, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare