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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
History of Changes

November 3, 2008
October 31, 2011
March 2010
April 2010   (final data collection date for primary outcome measure)
  • Observed Plasma Gabapentin Concentration [ Time Frame: Days 8 and 15 ] [ Designated as safety issue: No ]
    Plasma gabapentin concentrations were measured on Day 8 and Day 15
  • Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model [ Time Frame: Days 8 and 15 ] [ Designated as safety issue: No ]
    Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.
  • Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration [ Time Frame: Days 8 and 15 ] [ Designated as safety issue: No ]
    Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Pharmacokinetics: measuring plasma Gabapentin concentration [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00785772 on ClinicalTrials.gov Archive Site
Not Provided
Safety: adverse events, laboratory data, physical examination, blood pressure, pulse rate, and body weight [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

  • NA
Both
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00785772
A9451169
No
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