An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00584779

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
Renal Impairment	Drug: Gabapentin	Phase IV

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Gabapentin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584779

Locations

Japan, Kagoshima-Ken
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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A9451160
Study First Received:	December 21, 2007
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00584779
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Gabapentin Pharmacokinetics

Study placed in the following topic categories:

Excitatory Amino Acids
Calcium, Dietary
Gabapentin

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009