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Trial record 1 of 1 for:    NCT00785772
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A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

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ClinicalTrials.gov Identifier: NCT00785772
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 5, 2008
Results First Posted : April 27, 2011
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE November 3, 2008
First Posted Date  ICMJE November 5, 2008
Results First Submitted Date  ICMJE March 29, 2011
Results First Posted Date  ICMJE April 27, 2011
Last Update Posted Date February 3, 2021
Study Start Date  ICMJE March 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
  • Observed Plasma Gabapentin Concentration [ Time Frame: Days 8 and 15 ]
    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 [ Time Frame: Days 8 and 15 ]
    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 [ Time Frame: Days 8 and 15 ]
    Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
Pharmacokinetics: measuring plasma Gabapentin concentration [ Time Frame: March 2010 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
Safety: adverse events, laboratory data, physical examination, blood pressure, pulse rate, and body weight [ Time Frame: March 2010 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Official Title  ICMJE A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Impairment
Intervention  ICMJE
  • Drug: Gabapentin
    100-200mg once a day
  • Drug: Gabapentin
    200-500mg once a day
  • Drug: Gabapentin
    400-1000mg (200-500 mg twice a day)
Study Arms  ICMJE
  • Experimental: 1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min
    Intervention: Drug: Gabapentin
  • Experimental: 2: Patients with CLcr 15-29 mL/min
    Intervention: Drug: Gabapentin
  • Experimental: 3: Patients with CLcr 30-59 mL/min
    Intervention: Drug: Gabapentin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 5, 2010)
1
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2008)
10
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese epilepsy patients with renal impairment

Exclusion Criteria:

  • NA
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00785772
Other Study ID Numbers  ICMJE A9451169
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP