We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    A9451169
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00785772
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 5, 2008
Results First Posted : April 27, 2011
Last Update Posted : November 16, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Renal Impairment Drug: Gabapentin Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Study Start Date : March 2010
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Observed Plasma Gabapentin Concentration [ Time Frame: Days 8 and 15 ]
    Plasma gabapentin concentrations were measured on Day 8 and Day 15

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Japanese epilepsy patients with renal impairment

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785772


Locations
Japan
Pfizer Investigational Site
Saijyo-shi, Ehime, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00785772     History of Changes
Other Study ID Numbers: A9451169
First Posted: November 5, 2008    Key Record Dates
Results First Posted: April 27, 2011
Last Update Posted: November 16, 2011
Last Verified: October 2011

Keywords provided by Pfizer:
Gabapentin Pharmacokinetics

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
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