An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

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NCT00584779

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Study Location
Pfizer Investigational Site
Aira-gun, Aira-cho, Kagoshima-ken, , Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
PK Properties Of Gabapentin In Subjects With Impaired Renal Function
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- The subjects whose creatinine clearance is 5-59 mL/min, or hemodialysis patients.

- The hemodialysis patients who enter this study is required hemodialysis for at least six weeks (the frequency is three times per week)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Renal allograft recipients

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PK Properties Of Gabapentin In Subjects With Impaired Renal FunctionAn Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
NCT00584779
  1. Aira-gun, Aira-cho, Kagoshima-ken
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Official Title  ICMJE An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Brief Summary To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package insert to Japanese.
Detailed Description The study was terminated on September 30, 2008 at the current study site due to reported adverse events in the study subjects (n=8). While the adverse events reported were generally consistent with the known profile of gabapentin, it was decided that the study should continue at a different study site. The pharmacokinetics of gabapentin in the subjects with renal impairment will be evaluated in a separate study with a different study number at a different site. The study will be entitled: "The Pharmacokinetic Study of Gabapentin in Japanese Epileptic Subjects with Renal Impairment".
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE PK Properties Of Gabapentin In Subjects With Impaired Renal Function
Intervention  ICMJE
  • Drug: Gabapentin
    CLcr:14-5 mL/min
  • Drug: Gabapentin
    CLcr: 29-15 mL/min
  • Drug: Gabapentin
    Hemodialysis
  • Drug: Gabapentin
    CLcr: 29-30 mL/min
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Gabapentin
  • Experimental: 2
    Intervention: Drug: Gabapentin
  • Experimental: 3
    Intervention: Drug: Gabapentin
  • Experimental: 4
    Intervention: Drug: Gabapentin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 28, 2008)		8
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)		20
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subjects whose creatinine clearance is 5-59 mL/min, or hemodialysis patients.
  • The hemodialysis patients who enter this study is required hemodialysis for at least six weeks (the frequency is three times per week)

Exclusion Criteria:

  • Renal allograft recipients
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00584779
Other Study ID Numbers  ICMJE A9451160
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP