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An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

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: NCT00584779
Recruitment Status : Terminated (See detailed description for termination reason)
First Posted : January 2, 2008
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package insert to Japanese.

Condition or disease Intervention/treatment Phase
PK Properties Of Gabapentin In Subjects With Impaired Renal Function Drug: Gabapentin Phase 4

Detailed Description:
The study was terminated on September 30, 2008 at the current study site due to reported adverse events in the study subjects (n=8). While the adverse events reported were generally consistent with the known profile of gabapentin, it was decided that the study should continue at a different study site. The pharmacokinetics of gabapentin in the subjects with renal impairment will be evaluated in a separate study with a different study number at a different site. The study will be entitled: "The Pharmacokinetic Study of Gabapentin in Japanese Epileptic Subjects with Renal Impairment".

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Study Start Date : October 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Gabapentin
CLcr: 29-30 mL/min
Experimental: 2 Drug: Gabapentin
CLcr: 29-15 mL/min
Experimental: 3 Drug: Gabapentin
CLcr:14-5 mL/min
Experimental: 4 Drug: Gabapentin
Hemodialysis


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: dec 2008 ]

Secondary Outcome Measures :
  1. There were no secondary outcomes measures for this study [ Time Frame: dec 2008 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subjects whose creatinine clearance is 5-59 mL/min, or hemodialysis patients.
  • The hemodialysis patients who enter this study is required hemodialysis for at least six weeks (the frequency is three times per week)

Exclusion Criteria:

  • Renal allograft recipients
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): NCT00584779


Locations
Japan
Pfizer Investigational Site
Aira-gun, Aira-cho, Kagoshima-ken, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00584779     History of Changes
Other Study ID Numbers: A9451160
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: October 2008

Keywords provided by Pfizer:
Gabapentin Pharmacokinetics, renal impairment

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