A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
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...
Brief Summary
Official Title: “A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: April 2010
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Gabapentin
- 100-200mg once a day
- Drug: Gabapentin
- 200-500mg once a day
- Drug: Gabapentin
- 400-1000mg (200-500 mg twice a day)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min
- Experimental: 2: Patients with CLcr 15-29 mL/min
- Experimental: 3: Patients with CLcr 30-59 mL/min
Outcome Measures for this Clinical Trial
Primary Measures
- Observed Plasma Gabapentin Concentration
- Time Frame: Days 8 and 15
Safety Issue?: No
- Time Frame: Days 8 and 15
- Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
- Time Frame: Days 8 and 15
Safety Issue?: No
- Time Frame: Days 8 and 15
- Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
- Time Frame: Days 8 and 15
Safety Issue?: No
- Time Frame: Days 8 and 15
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Japanese epilepsy patients with renal impairment
Exclusion Criteria:
- NA
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00785772
Study ID Number: A9451169
ClinicalTrials.gov Identifier: NCT00785772
Health Authority: Japan: Ministry of Health, Labor and Welfare
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00785772
