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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.)
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 3, 2008
Last updated: October 31, 2011
Last verified: October 2011
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.

Condition Intervention Phase
Renal Impairment
Drug: Gabapentin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Observed Plasma Gabapentin Concentration [ Time Frame: Days 8 and 15 ]
    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 ]
    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 ]
    Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.

Enrollment: 1
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min Drug: Gabapentin
100-200mg once a day
Other Name: Not specified
Experimental: 2: Patients with CLcr 15-29 mL/min Drug: Gabapentin
200-500mg once a day
Experimental: 3: Patients with CLcr 30-59 mL/min Drug: Gabapentin
400-1000mg (200-500 mg twice a day)

Detailed Description:
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.

Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Japanese epilepsy patients with renal impairment

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00785772

Pfizer Investigational Site
Saijyo-shi, Ehime, Japan
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00785772     History of Changes
Other Study ID Numbers: A9451169
Study First Received: November 3, 2008
Results First Received: March 29, 2011
Last Updated: October 31, 2011

Keywords provided by Pfizer:
Gabapentin Pharmacokinetics

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents processed this record on May 25, 2017