Recent Updates
Recently added Catalysts

Triazolam

Phase 3

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 21, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

Triazolam · 1 trial · 1 indication

Phase 3 1
NCT01888497Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal VolunteersHealthy
COMPLETED59 Analytics
PHASE3COMPLETED
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Standard Deviation of Lateral Position (SDLP)
7.25 hours post-dose

Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). SDLP was used to assess driver's ability to track their lane and was the standard deviation of lane positions through the entire drive.

Secondary Endpoints

Speed Deviation
7.25 hours post dose
Lane Exceedance
7.25 hours post-dose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CACTIVE_COMPARATOR -
Arm DPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GabapentinDRUG250 mg, oral, prior to bedtime on the night before performance testing
Diphenhydramine citrateDRUG76 mg, oral, prior to bedtime on the night before performance testing
TriazolamDRUG0.5 mg, oral, prior to bedtime on the night before performance testing
PlaceboDRUGOral, prior to bedtime on the night before performance testing
Unlock Study Design Details

Eligibility Criteria

Age Range25 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Healthy males and females of non-childbearing potential, 25-55 years of age * Valid driver's license Exclusion Criteria: * Psychiatric disorder * Recent history of clinically significant neurological disorder, such as seizures, stroke, multiple sclerosis, or head trauma * Re...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Triazolam

What is Triazolam used for?

Triazolam is a small molecule being studied in healthy volunteers. It is being investigated for its effects on next-day residual performance, specifically in the context of simulated driving. The drug is currently in Phase 3 clinical development.

Who makes Triazolam?

Triazolam is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical development.

What phase is Triazolam in?

Triazolam is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 3 clinical trial has been completed.

What clinical trials is Triazolam in?

Triazolam has been studied in one completed Phase 3 clinical trial, identified as NCT01888497. This trial examined the next-day residual effects of Triazolam on simulated driving performance in normal volunteers.

Is Triazolam the same as gabapentin or diphenhydramine?

Triazolam is not the same as gabapentin or diphenhydramine. In a clinical trial, these three drugs were studied together to compare their next-day residual effects on simulated driving performance in healthy volunteers.