A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment | RxWiki

A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

Overview[ - collapse ][ - ]

Purpose	The primary objectives of this study are to evaluate the pharmacokinetics (PK) 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	Renal Impairment
Intervention	Drug: Gabapentin Drug: Gabapentin Drug: Gabapentin
Phase	Phase 4
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT00785772
First Received	November 3, 2008
Last Updated	October 31, 2011
Last verified	October 2011

Tracking Information[ + expand ][ + ]

First Received Date	November 3, 2008
Last Updated Date	October 31, 2011
Start Date	March 2010
Estimated Primary Completion Date	April 2010
Current Primary Outcome Measures	Observed Plasma Gabapentin Concentration [Time Frame: Days 8 and 15] [Designated as safety issue: No]Plasma gabapentin concentrations were measured on Day 8 and Day 15 Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model [Time Frame: Days 8 and 15] [Designated as safety issue: No]Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively. Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration [Time Frame: Days 8 and 15] [Designated as safety issue: No]Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Official Title	A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Brief Summary	The primary objectives of this study are to evaluate the pharmacokinetics (PK) 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.
Detailed Description	Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Renal Impairment
Intervention	Drug: Gabapentin 100-200mg once a day Other Names: Not specifiedDrug: Gabapentin 200-500mg once a day Drug: Gabapentin 400-1000mg (200-500 mg twice a day)
Study Arm (s)	Experimental: 1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min Experimental: 2: Patients with CLcr 15-29 mL/min Experimental: 3: Patients with CLcr 30-59 mL/min

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	1
Estimated Completion Date	April 2010
Estimated Primary Completion Date	April 2010
Eligibility Criteria	Inclusion Criteria: - Japanese epilepsy patients with renal impairment Exclusion Criteria: - NA
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Japan

Administrative Information[ + expand ][ + ]

NCT Number	NCT00785772
Other Study ID Numbers	A9451169
Has Data Monitoring Committee	No
Information Provided By	Pfizer
Study Sponsor	Pfizer
Collaborators	Not Provided
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
Verification Date	October 2011

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