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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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Gabapentin Drug: Diphenhydramine citrate Drug: Triazolam Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
Experimental: Arm A Drug: Gabapentin
250 mg, oral, prior to bedtime on the night before performance testing

Experimental: Arm B Drug: Diphenhydramine citrate
76 mg, oral, prior to bedtime on the night before performance testing

Active Comparator: Arm C Drug: Triazolam
0.5 mg, oral, prior to bedtime on the night before performance testing

Placebo Comparator: Arm D Drug: Placebo
Oral, prior to bedtime on the night before performance testing




Primary Outcome Measures :
  1. Standard Deviation of Lateral Position [ Time Frame: 7.25 hours post dosing ]

Secondary Outcome Measures :
  1. Speed Deviation [ Time Frame: 7.25 hours post dosing ]
  2. Lane Exceedances [ Time Frame: 7.25 hours post dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888497


Locations
United States, Florida
Baptist Sleep Centers, LLP
South Miami, Florida, United States, 33143
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Georgia
NeuroTrials Research Sleep Lab
Atlanta, Georgia, United States, 30342
NeuroTrials Research, Inc.
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01888497     History of Changes
Other Study ID Numbers: A9451178
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: December 2014

Keywords provided by Pfizer:
Sleeplessness

Additional relevant MeSH terms:
Gabapentin
Triazolam
Diphenhydramine
gamma-Aminobutyric Acid
Promethazine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents
Anesthetics, Local
Anesthetics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists