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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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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".

Conditions

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PK Properties Of Gabapentin In Subjects With Impaired Renal Function

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

CLcr:14-5 mL/min

Intervention Type DRUG

Gabapentin

CLcr: 29-15 mL/min

Intervention Type DRUG

Gabapentin

Hemodialysis

Intervention Type DRUG

Gabapentin

CLcr: 29-30 mL/min

Intervention Type DRUG

Eligibility Criteria

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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)