A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Impairment
Intervention: Gabapentin (Drug); Gabapentin (Drug); Gabapentin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Observed Plasma Gabapentin ConcentrationRatio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Japanese epilepsy patients with renal impairment
Exclusion Criteria:
- NA
Locations and Contacts
Pfizer Investigational Site, Saijyo-shi, Ehime, Japan
Additional Information
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Starting date: March 2010
Last updated: October 31, 2011
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