Back to resultsAn Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Primary Purpose
PK Properties Of Gabapentin In Subjects With Impaired Renal Function
Status
Terminated
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Gabapentin
Gabapentin
Gabapentin
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for PK Properties Of Gabapentin In Subjects With Impaired Renal Function focused on measuring Gabapentin Pharmacokinetics, renal impairment
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Renal allograft recipients
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics
Secondary Outcome Measures
There were no secondary outcomes measures for this study
Full Information
NCT ID
NCT00584779
First Posted
December 21, 2007
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00584779
Brief Title
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Official Title
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Why Stopped
See detailed description for termination reason
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (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
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.
Detailed Description
The study was terminated on September 30, 2008 at the current study site due to reported adverse events in the study subjects (n=8). While the adverse events reported were generally consistent with the known profile of gabapentin, it was decided that the study should continue at a different study site. The pharmacokinetics of gabapentin in the subjects with renal impairment will be evaluated in a separate study with a different study number at a different site. The study will be entitled: "The Pharmacokinetic Study of Gabapentin in Japanese Epileptic Subjects with Renal Impairment".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PK Properties Of Gabapentin In Subjects With Impaired Renal Function
Keywords
Gabapentin Pharmacokinetics, renal impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
CLcr:14-5 mL/min
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
CLcr: 29-15 mL/min
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Hemodialysis
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
CLcr: 29-30 mL/min
Primary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
dec 2008
Secondary Outcome Measure Information:
Title
There were no secondary outcomes measures for this study
Time Frame
dec 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Renal allograft recipients
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
Aira-gun, Aira-cho
State/Province
Kagoshima-ken
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451160&StudyName=An%20Open%20Label%20Pharmacokinetic%20Study%20Of%20Gabapentin%20%0AIn%20Japanese%20Subjects%20With%20Renal%20Impairment%0AIncluding%20Hemodialysis%0A
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
We'll reach out to this number within 24 hrs