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A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
1 other identifier
interventional
1
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
April 27, 2011
CompletedFebruary 3, 2021
October 1, 2011
1 month
November 3, 2008
March 29, 2011
February 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Observed Plasma Gabapentin Concentration
Plasma gabapentin concentrations were measured on Day 8 and Day 15
Days 8 and 15
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.
Days 8 and 15
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Days 8 and 15
Study Arms (3)
1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min
EXPERIMENTAL2: Patients with CLcr 15-29 mL/min
EXPERIMENTAL3: Patients with CLcr 30-59 mL/min
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Japanese epilepsy patients with renal impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Saijyo-shi, Ehime, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was completed with an enrollment of 1 subject because prolongation of the study period or a change in the inclusion criteria (the upper limit of age was deleted) did not lead to further enrollment of subjects.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 5, 2008
Study Start
March 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 3, 2021
Results First Posted
April 27, 2011
Record last verified: 2011-10