Trial · NCT00581893
Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study
NCT00581893, Phase 4, Completed, University of Iowa; results first posted 2021-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study. Trials, record NCT00581893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00581893
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study
- NCT number
- NCT00581893
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Iowa
- Conditions
- Cognitive Measures, Driving Simulator Performance
- Interventions
- Phenytoin, Placebo oral capsule
- First posted
- 2007-12-28
- Last updated
- 2021-07-01
- Results first posted
- 2021-07-01
- Limitations and caveats
- The very small sample size of evaluable subjects prevents definitive conclusions on the safety hazards of phenytoin for driving performance.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Had a Driving Simulator Crash Event | 1 month | Number of subjects who had a crash event during the driving simulator test. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Who Had a Driving Simulator Crash Event | 1 month | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Had a Driving Simulator Crash Event | Phenytoin | 2 | Participants | ||
| Number of Subjects Who Had a Driving Simulator Crash Event | Placebo | 0 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (1 Month) | STARTED | Phenytoin First, Then Placebo | 10 | |
| First Intervention (1 Month) | STARTED | Placebo First, Then Phentoin | 10 | |
| First Intervention (1 Month) | COMPLETED | Phenytoin First, Then Placebo | 10 | |
| First Intervention (1 Month) | COMPLETED | Placebo First, Then Phentoin | 10 | |
| First Intervention (1 Month) | NOT COMPLETED | Phenytoin First, Then Placebo | 0 | |
| First Intervention (1 Month) | NOT COMPLETED | Placebo First, Then Phentoin | 0 | |
| Washout (14 Days) | STARTED | Phenytoin First, Then Placebo | 10 | |
| Washout (14 Days) | STARTED | Placebo First, Then Phentoin | 10 | |
| Washout (14 Days) | COMPLETED | Phenytoin First, Then Placebo | 10 | |
| Washout (14 Days) | COMPLETED | Placebo First, Then Phentoin | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenytoin | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Phenytoin | 0 | 20 |
| Total, other adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Phenytoin | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R49CE721682 | Grant for Injury control research center | PEEK-ASA, CORINNE | UNIVERSITY OF IOWA | NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL | 2005 to 2006 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phenytoin vs Placebo: Number of Subjects Who Had a Driving Simulator Crash Event | Trial comparisons |
| Phenytoin vs Placebo: deaths from any cause | Trial comparisons |
| Phenytoin vs Placebo: serious adverse events | Trial comparisons |
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/NCT00581893
GET https://conductscience.org/api/trials/v1/NCT00581893/registered