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

NCT ID: NCT00785772

Last Updated: 2021-02-03

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

100-200mg once a day

2: Patients with CLcr 15-29 mL/min

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

200-500mg once a day

3: Patients with CLcr 30-59 mL/min

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

400-1000mg (200-500 mg twice a day)

Interventions

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Gabapentin

100-200mg once a day

Intervention Type DRUG

Gabapentin

200-500mg once a day

Intervention Type DRUG

Gabapentin

400-1000mg (200-500 mg twice a day)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese epilepsy patients with renal impairment

Exclusion Criteria

* NA
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Saijyo-shi, Ehime, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451169&StudyName=A%20Post-Marketing%20Clinical%20Pharmacokinetics%20Study%20Of%20Gabapentin%20In%20Japanese%20Epileptic%20Subjects%20With%20Renal%20Impairment

To obtain contact information for a study center near you, click here.

Other Identifiers

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A9451169

Identifier Type: -

Identifier Source: org_study_id

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