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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00584779
• Date of registration: 21/12/2007
• Primary sponsor: Pfizer
• Public title: An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
• Scientific title: An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
• Date of first enrolment: October 2007
• Target sample size: 8
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00584779
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

PK Properties Of Gabapentin In Subjects With Impaired Renal Function

Intervention(s)

Drug: Gabapentin

Primary Outcome(s)

Pharmacokinetics [Time Frame: dec 2008]

Secondary Outcome(s)

There were no secondary outcomes measures for this study [Time Frame: dec 2008]

Secondary ID(s)

A9451160

Source(s) of Monetary Support

Please refer to primary and secondary sponsors