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

NCT01888497

Last updated date
Study Location
Baptist Sleep Centers, LLP
South Miami, Florida, 33143, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2014)
59
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
52
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888497
Other Study ID Numbers  ICMJE A9451178
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP