Trial · NCT00785772
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
NCT00785772, Phase 4, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment. Trials, record NCT00785772. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00785772
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
- NCT number
- NCT00785772
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 1 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Renal Impairment
- Interventions
- Gabapentin, Gabapentin, Gabapentin
- First posted
- 2008-11-05
- Last updated
- 2021-02-03
- Results first posted
- 2011-04-27
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Observed Plasma Gabapentin Concentration | Days 8 and 15 | Plasma gabapentin concentrations were measured on Day 8 and Day 15 |
| Primary | Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | 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. |
| Primary | Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Observed Plasma Gabapentin Concentration | Days 8 and 15 | The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest. | µg/mL | MEAN |
| PRIMARY | Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | Days 8 and 15 | The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest. | Ratio | NUMBER |
| PRIMARY | Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | Days 8 and 15 | The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest. | Ratio | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Observed Plasma Gabapentin Concentration | Gabapentin | Day 8 | 38.40 | Full Range 38.40 to 38.40 | µg/mL |
| Observed Plasma Gabapentin Concentration | Gabapentin | Day 15 | 44.64 | Full Range 44.64 to 44.64 | µg/mL |
| Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | Gabapentin | Day 8 | 2.16 | Ratio | |
| Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | Gabapentin | Day 15 | 2.59 | Ratio | |
| Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | Gabapentin | Day 8 | 1.15 | Ratio | |
| Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | Gabapentin | Day 15 | 1.37 | Ratio |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin | 1 | |
| Overall Study | COMPLETED | Gabapentin | 1 | |
| Overall Study | NOT COMPLETED | Gabapentin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | ||
| Total, other adverse events | Gabapentin | 0 | 1 |
| Total, serious adverse events | Gabapentin | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00785772
GET https://conductscience.org/api/trials/v1/NCT00785772/registered