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Trial record 1 of 1 for:    NCT01888497
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Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

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ClinicalTrials.gov Identifier: NCT01888497
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date January 6, 2015
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Standard Deviation of Lateral Position [ Time Frame: 7.25 hours post dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01888497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Speed Deviation [ Time Frame: 7.25 hours post dosing ]
  • Lane Exceedances [ Time Frame: 7.25 hours post dosing ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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