NCT00584779

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
Last Updated

February 2, 2021

Status Verified

October 1, 2008

Enrollment Period

2 months

First QC Date

December 21, 2007

Last Update Submit

February 1, 2021

Conditions

PK Properties Of Gabapentin In Subjects With Impaired Renal Function

Keywords

Gabapentin Pharmacokinetics, renal impairment

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    dec 2008

Secondary Outcomes (1)

  • There were no secondary outcomes measures for this study

    dec 2008

Study Arms (4)

1

EXPERIMENTAL
Drug: Gabapentin

2

EXPERIMENTAL
Drug: Gabapentin

3

EXPERIMENTAL
Drug: Gabapentin

4

EXPERIMENTAL
Drug: Gabapentin

Interventions

GabapentinDRUG

CLcr:14-5 mL/min

3

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Renal allograft recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Aira-gun, Aira-cho, Kagoshima-ken, Japan

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 2, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 2, 2021

Record last verified: 2008-10

Locations

JP(1)