Trial Outcomes & Findings for A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment (NCT NCT00785772)
NCT ID: NCT00785772
Last Updated: 2021-02-03
Results Overview
Plasma gabapentin concentrations were measured on Day 8 and Day 15
TERMINATED
PHASE4
1 participants
Days 8 and 15
2021-02-03
Participant Flow
Study Initiation Date and Completion Dates: 16 March 2010 to 1 April 2010 Study Center: 1 center in Japan
A subject who had already been taking gabapentin was enrolled in the study.
Participant milestones
| Measure |
Gabapentin
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.
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|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
Baseline characteristics by cohort
| Measure |
Gabapentin
n=1 Participants
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.
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|---|---|
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Age, Customized
<=19 years
|
0 Participant
n=5 Participants
|
|
Age, Customized
20-64 years
|
1 Participant
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 Participant
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 8 and 15Population: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
Plasma gabapentin concentrations were measured on Day 8 and Day 15
Outcome measures
| Measure |
Gabapentin
n=1 Participants
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.
|
|---|---|
|
Observed Plasma Gabapentin Concentration
Day 8
|
38.40 µg/mL
Interval 38.4 to 38.4
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|
Observed Plasma Gabapentin Concentration
Day 15
|
44.64 µg/mL
Interval 44.64 to 44.64
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PRIMARY outcome
Timeframe: Days 8 and 15Population: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
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.
Outcome measures
| Measure |
Gabapentin
n=1 Participants
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.
|
|---|---|
|
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Day 8
|
2.16 Ratio
|
|
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Day 15
|
2.59 Ratio
|
PRIMARY outcome
Timeframe: Days 8 and 15Population: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Outcome measures
| Measure |
Gabapentin
n=1 Participants
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.
|
|---|---|
|
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Day 8
|
1.15 Ratio
|
|
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Day 15
|
1.37 Ratio
|
Adverse Events
Gabapentin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER