Back to resultsA Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Primary Purpose
Renal Impairment
Status
Terminated
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Gabapentin
Gabapentin
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Renal Impairment focused on measuring Gabapentin Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Japanese epilepsy patients with renal impairment
Exclusion Criteria:
- NA
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min
2: Patients with CLcr 15-29 mL/min
3: Patients with CLcr 30-59 mL/min
Arm Description
Outcomes
Primary Outcome Measures
Observed Plasma Gabapentin Concentration
Plasma gabapentin concentrations were measured on Day 8 and Day 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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00785772
First Posted
November 3, 2008
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00785772
Brief Title
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Official Title
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
Gabapentin Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min
Arm Type
Experimental
Arm Title
2: Patients with CLcr 15-29 mL/min
Arm Type
Experimental
Arm Title
3: Patients with CLcr 30-59 mL/min
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
100-200mg once a day
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
200-500mg once a day
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
400-1000mg (200-500 mg twice a day)
Primary Outcome Measure Information:
Title
Observed Plasma Gabapentin Concentration
Description
Plasma gabapentin concentrations were measured on Day 8 and Day 15
Time Frame
Days 8 and 15
Title
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Description
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.
Time Frame
Days 8 and 15
Title
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Description
Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Time Frame
Days 8 and 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Japanese epilepsy patients with renal impairment
Exclusion Criteria:
NA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Saijyo-shi
State/Province
Ehime
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451169&StudyName=A%20Post-Marketing%20Clinical%20Pharmacokinetics%20Study%20Of%20Gabapentin%20In%20Japanese%20Epileptic%20Subjects%20With%20Renal%20Impairment
Description
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A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
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