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

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kagoshima-ken
      • Aira-gun, Aira-cho, Kagoshima-ken, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Gabapentin
CLcr:14-5 mL/min
Drug: Gabapentin
CLcr: 29-15 mL/min
Drug: Gabapentin
Hemodialysis
Drug: Gabapentin
CLcr: 29-30 mL/min
Experimental: 2
Drug: Gabapentin
CLcr:14-5 mL/min
Drug: Gabapentin
CLcr: 29-15 mL/min
Drug: Gabapentin
Hemodialysis
Drug: Gabapentin
CLcr: 29-30 mL/min
Experimental: 3
Drug: Gabapentin
CLcr:14-5 mL/min
Drug: Gabapentin
CLcr: 29-15 mL/min
Drug: Gabapentin
Hemodialysis
Drug: Gabapentin
CLcr: 29-30 mL/min
Experimental: 4
Drug: Gabapentin
CLcr:14-5 mL/min
Drug: Gabapentin
CLcr: 29-15 mL/min
Drug: Gabapentin
Hemodialysis
Drug: Gabapentin
CLcr: 29-30 mL/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: dec 2008
dec 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
There were no secondary outcomes measures for this study
Time Frame: dec 2008
dec 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9451160

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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