A Post-Marketing Clinical Pharmakokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00785772

Purpose

The primary objectives of this study are to evaluate the pharmacokinetics 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	Intervention	Phase
Renal Impairment	Drug: Gabapentin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Post-Marketing Clinical Pharmakokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Pharmacokinetics: measuring plasma Gabapentin concentration [ Time Frame: Days 0, 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: adverse events, laboratory data, physical examination, blood pressure, pulse rate, and body weight [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	February 2010
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Gabapentin CLcr:14-5 mL/min 100-200mg/day QD
2: Experimental	Drug: Gabapentin CLcr: 29-15 mL/min 200-500mg/day QD
3: Experimental	Drug: Gabapentin CLcr: 59-30 mL/min 400-100mg/day BID

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Japanese epilepsy patients with renal impairment

Exclusion Criteria:

NA

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785772

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9451169
Study First Received:	November 3, 2008
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00785772 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Gabapentin Pharmacokinetics

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
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 February 09, 2010