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

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

Overview[ - collapse ][ - ]

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	PK Properties Of Gabapentin In Subjects With Impaired Renal Function
Intervention	Drug: Gabapentin Drug: Gabapentin Drug: Gabapentin Drug: Gabapentin
Phase	Phase 4
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT00584779
First Received	December 21, 2007
Last Updated	March 11, 2009
Last verified	October 2008

Tracking Information[ + expand ][ + ]

First Received Date	December 21, 2007
Last Updated Date	March 11, 2009
Start Date	October 2007
Estimated Primary Completion Date	December 2007
Current Primary Outcome Measures	Pharmacokinetics [Time Frame: dec 2008] [Designated as safety issue: No]
Current Secondary Outcome Measures	There were no secondary outcomes measures for this study [Time Frame: dec 2008] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Official Title	An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Brief Summary	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.
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".
Study Type	Interventional
Study Phase	Phase 4
Study Design	Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	PK Properties Of Gabapentin In Subjects With Impaired Renal Function
Intervention	Drug: Gabapentin CLcr:14-5 mL/min Drug: Gabapentin CLcr: 29-15 mL/min Drug: Gabapentin Hemodialysis Drug: Gabapentin CLcr: 29-30 mL/min
Study Arm (s)	Experimental: 1 Experimental: 2 Experimental: 3 Experimental: 4

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	8
Estimated Completion Date	December 2007
Estimated Primary Completion Date	December 2007
Eligibility 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
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Japan

Administrative Information[ + expand ][ + ]

NCT Number	NCT00584779
Other Study ID Numbers	A9451160
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 2008

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