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

• ClinicalTrials.gov Identifier: NCT01888497
• Recruitment Status: Completed
• First Posted: June 27, 2013
• Results First Posted: February 5, 2021
• Last Update Posted: February 21, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: June 25, 2013
• First Posted Date: June 27, 2013
• Results First Submitted Date: November 12, 2020
• Results First Posted Date: February 5, 2021
• Last Update Posted Date: February 21, 2021
• Actual Study Start Date: July 29, 2013
• Actual Primary Completion Date: December 14, 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 19, 2021)

Standard Deviation of Lateral Position (SDLP) [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: June 25, 2013): Standard Deviation of Lateral Position [ Time Frame: 7.25 hours post dosing ]

Current Secondary Outcome Measures (submitted: January 19, 2021)

• Speed Deviation [ Time Frame: 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). Standard deviation of speed was reported in the outcome measure.
• Lane Exceedance [ Time Frame: 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). Mean lanes excursed/exceeded was reported in the outcome measure.

Original Secondary Outcome Measures (submitted: June 25, 2013)

• Speed Deviation [ Time Frame: 7.25 hours post dosing ]
• Lane Exceedance [ Time Frame: 7.25 hours post dosing ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
• Official Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CROSS-OVER, PLACEBO-CONTROLLED, 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 13, 2014): 59
• Original Estimated Enrollment (submitted: June 25, 2013): 52
• Actual Study Completion Date: December 14, 2013
• Actual Primary Completion Date: December 14, 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 25 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01888497
• Other Study ID Numbers: A9451178
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2021