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Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Baptist Sleep Centers, LLP
South Miami, Florida, 33143 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
25-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males and females of non-childbearing potential, 25-55 years of age

- Valid driver's license

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Psychiatric disorder

- Recent history of clinically significant neurological disorder, such as seizures,
stroke, multiple sclerosis, or head trauma

- Recent histroy or current treatment for sleep disorder

NCT01888497
Pfizer
Completed
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

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Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
A Phase 3 Randomized, Double-blind, Cross-over, Placebo-controlled, Multi-center, Single-dose, Clinical Trial to Assess the Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal volunteer subjects. It will also examine other measures of next-day performance and next-day sleepiness.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: Gabapentin
    250 mg, oral, prior to bedtime on the night before performance testing
  • Drug: Diphenhydramine citrate
    76 mg, oral, prior to bedtime on the night before performance testing
  • Drug: Triazolam
    0.5 mg, oral, prior to bedtime on the night before performance testing
  • Drug: Placebo
    Oral, prior to bedtime on the night before performance testing
  • Experimental: Arm A
    Intervention: Drug: Gabapentin
  • Experimental: Arm B
    Intervention: Drug: Diphenhydramine citrate
  • Active Comparator: Arm C
    Intervention: Drug: Triazolam
  • Placebo Comparator: Arm D
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
  • Recent histroy or current treatment for sleep disorder
Sexes Eligible for Study: All
25 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01888497
A9451178
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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