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

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NCT00584779

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aira-gun, Aira-cho, Kagoshima-ken, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- 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.
Show details

- Renal allograft recipients

NCT00584779
Pfizer
Terminated
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

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An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
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.
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".
Interventional
Phase 4
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
PK Properties Of Gabapentin In Subjects With Impaired Renal Function
  • Drug: Gabapentin
    CLcr:14-5 mL/min
  • Drug: Gabapentin
    CLcr: 29-15 mL/min
  • Drug: Gabapentin
    Hemodialysis
  • Drug: Gabapentin
    CLcr: 29-30 mL/min
  • Experimental: 1
    Intervention: Drug: Gabapentin
  • Experimental: 2
    Intervention: Drug: Gabapentin
  • Experimental: 3
    Intervention: Drug: Gabapentin
  • Experimental: 4
    Intervention: Drug: Gabapentin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00584779
A9451160
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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