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
• Last Update Posted: January 6, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: June 25, 2013
• First Posted Date: June 27, 2013
• Last Update Posted Date: January 6, 2015
• Study Start Date: July 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 25, 2013): Standard Deviation of Lateral Position [ Time Frame: 7.25 hours post dosing ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01888497 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• 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, 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: 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 2013
• Actual Primary Completion Date: December 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: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pfizer
• Verification Date: December 2014