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

This study has been terminated.
(See detailed description for termination reason)
Information provided by:
Pfizer Identifier:
First received: December 21, 2007
Last updated: March 11, 2009
Last verified: October 2008
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 Intervention Phase
PK Properties Of Gabapentin In Subjects With Impaired Renal Function Drug: Gabapentin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: dec 2008 ]

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

Enrollment: 8
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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".

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00584779

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

Additional Information:
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc. Identifier: NCT00584779     History of Changes
Other Study ID Numbers: A9451160
Study First Received: December 21, 2007
Last Updated: March 11, 2009

Keywords provided by Pfizer:
Gabapentin Pharmacokinetics, renal impairment

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 June 22, 2017