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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Saijyo-shi, Ehime, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Japanese epilepsy patients with renal impairment

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00785772
Pfizer
Terminated
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

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A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.
Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Impairment
  • Drug: Gabapentin
    100-200mg once a day
    Other Name: Not specified
  • Drug: Gabapentin
    200-500mg once a day
  • Drug: Gabapentin
    400-1000mg (200-500 mg twice a day)
  • Experimental: 1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min
    Intervention: Drug: Gabapentin
  • Experimental: 2: Patients with CLcr 15-29 mL/min
    Intervention: Drug: Gabapentin
  • Experimental: 3: Patients with CLcr 30-59 mL/min
    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
1
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Japanese epilepsy patients with renal impairment

Exclusion Criteria:

Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00785772
A9451169
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

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

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