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See termination reason in detailed description.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min | Experimental |
| |
| 2: Patients with CLcr 15-29 mL/min | Experimental |
| |
| 3: Patients with CLcr 30-59 mL/min | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 100-200mg once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Plasma Gabapentin Concentration | Plasma gabapentin concentrations were measured on Day 8 and Day 15 | Days 8 and 15 |
| Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | 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. | Days 8 and 15 |
| Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively. | Days 8 and 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Saijyo-shi | Ehime | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A subject who had already been taking gabapentin was enrolled in the study.
Study Initiation Date and Completion Dates: 16 March 2010 to 1 April 2010 Study Center: 1 center in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observed Plasma Gabapentin Concentration | Plasma gabapentin concentrations were measured on Day 8 and Day 15 | The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest. | Posted | Mean | Full Range | µg/mL | Days 8 and 15 |
|
From Day -7 (informed consent) until 28 days after the end of study treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Gabapentin |
| Drug |
200-500mg once a day |
|
| Gabapentin | Drug | 400-1000mg (200-500 mg twice a day) |
|
| Participant |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | 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. | The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest. | Posted | Number | Ratio | Days 8 and 15 |
|
|
|
| Primary | Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively. | The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest. | Posted | Number | Ratio | Days 8 and 15 |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
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.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |