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)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584779
First received: December 21, 2007
Last updated: March 11, 2009
Last verified: October 2008
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]

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

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
Hemodialysis

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".

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00584779     History of Changes
Other Study ID Numbers: A9451160
Study First Received: December 21, 2007
Last Updated: March 11, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
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

ClinicalTrials.gov processed this record on September 18, 2014