This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
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 : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min Drug: Gabapentin
100-200mg once a day
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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:

  • NA
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Japan
Pfizer Investigational Site
Saijyo-shi, Ehime, Japan
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00785772    
Other Study ID Numbers: A9451169
First Posted: November 5, 2008    Key Record Dates
Results First Posted: April 27, 2011
Last Update Posted: February 3, 2021
Last Verified: October 2011
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Gabapentin Pharmacokinetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents