An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

PK Properties Of Gabapentin In Subjects With Impaired Renal Function Clinical Trial

Official title:

An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00584779
• Other study ID #: A9451160
• Status: Terminated
• Phase: Phase 4
• Start date: October 2007
• Est. completion date: December 2007

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PK Properties Of Gabapentin In Subjects With Impaired Renal Function
• Renal Insufficiency

Intervention

Drug:
• Gabapentin
CLcr:14-5 mL/min
• Gabapentin
CLcr: 29-15 mL/min
• Gabapentin
Hemodialysis
• Gabapentin
CLcr: 29-30 mL/min

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Aira-gun, Aira-cho	Kagoshima-ken

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		dec 2008
Secondary	There were no secondary outcomes measures for this study		dec 2008

External Links

•   To obtain contact information for a study center near you, click here.