A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

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

Tracking Information

• First Submitted Date: November 3, 2008
• First Posted Date: November 5, 2008
• Results First Submitted Date: March 29, 2011
• Results First Posted Date: April 27, 2011
• Last Update Posted Date: February 3, 2021
• Study Start Date: March 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: November 3, 2008): Pharmacokinetics: measuring plasma Gabapentin concentration [ Time Frame: March 2010 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (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: 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Impairment

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 5, 2010): 1
• Original Estimated Enrollment (submitted: November 3, 2008): 10
• Actual Study Completion Date: April 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Japanese epilepsy patients with renal impairment

Exclusion Criteria:

• NA

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00785772
• Other Study ID Numbers: A9451169
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Original Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Current Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Original Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2011