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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 : November 16, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Impairment
Intervention Drug: Gabapentin
Enrollment 1

Recruitment Details Study Initiation Date and Completion Dates: 16 March 2010 to 1 April 2010 Study Center: 1 center in Japan
Pre-assignment Details A subject who had already been taking gabapentin was enrolled in the study.
Arm/Group Title Gabapentin
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The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Gabapentin
Hide Arm/Group Description

The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 1 participants
<=19 years 0
20-64 years 1
>=65 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Observed Plasma Gabapentin Concentration
Hide Description Plasma gabapentin concentrations were measured on Day 8 and Day 15
Time Frame Days 8 and 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
Arm/Group Title Gabapentin
Hide Arm/Group Description:

The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Overall Number of Participants Analyzed 1
Mean (Full Range)
Unit of Measure: µg/mL
Day 8
38.40
(38.40 to 38.40)
Day 15
44.64
(44.64 to 44.64)
2.Primary Outcome
Title Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Hide Description 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.
Time Frame Days 8 and 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
Arm/Group Title Gabapentin
Hide Arm/Group Description:

The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Ratio
Day 8 2.16
Day 15 2.59
3.Primary Outcome
Title Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Hide Description Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Time Frame Days 8 and 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
Arm/Group Title Gabapentin
Hide Arm/Group Description:

The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Ratio
Day 8 1.15
Day 15 1.37
Time Frame From Day -7 (informed consent) until 28 days after the end of study treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gabapentin
Hide Arm/Group Description

The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

All-Cause Mortality
Gabapentin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gabapentin
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gabapentin
Affected / at Risk (%)
Total   0/1 (0.00%) 
The study was completed with an enrollment of 1 subject because prolongation of the study period or a change in the inclusion criteria (the upper limit of age was deleted) did not lead to further enrollment of subjects.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00785772     History of Changes
Other Study ID Numbers: A9451169
First Submitted: November 3, 2008
First Posted: November 5, 2008
Results First Submitted: March 29, 2011
Results First Posted: April 27, 2011
Last Update Posted: November 16, 2011