You are here

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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aira-gun, Aira-cho, Kagoshima-ken, Japan
Contact
1-800-718-1021
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now