NCT01888497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for phase_3 healthy

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_3 healthy

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

July 29, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2013

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2021

Completed
Last Updated

February 21, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

June 25, 2013

Results QC Date

November 12, 2020

Last Update Submit

February 17, 2021

Conditions

Healthy

Keywords

Sleeplessness

Outcome Measures

Primary Outcomes (1)

  • Standard Deviation of Lateral Position (SDLP)

    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.

    7.25 hours post-dose

Secondary Outcomes (2)

  • Speed Deviation

    7.25 hours post dose

  • Lane Exceedance

    7.25 hours post-dose

Study Arms (4)

Arm A

EXPERIMENTAL
Drug: Gabapentin

Arm B

EXPERIMENTAL
Drug: Diphenhydramine citrate

Arm C

ACTIVE COMPARATOR
Drug: Triazolam

Arm D

PLACEBO COMPARATOR
Drug: Placebo

Interventions

GabapentinDRUG

250 mg, oral, prior to bedtime on the night before performance testing

Arm A
Diphenhydramine citrateDRUG

76 mg, oral, prior to bedtime on the night before performance testing

Arm B
TriazolamDRUG

0.5 mg, oral, prior to bedtime on the night before performance testing

Arm C
PlaceboDRUG

Oral, prior to bedtime on the night before performance testing

Arm D

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females of non-childbearing potential, 25-55 years of age
  • Valid driver's license

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Baptist Sleep Centers, LLP

South Miami, Florida, 33143, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

NeuroTrials Research Sleep Lab

Atlanta, Georgia, 30342, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

GabapentinDiphenhydramineTriazolam

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsEthylaminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 27, 2013

Study Start

July 29, 2013

Primary Completion

December 14, 2013

Study Completion

December 14, 2013

Last Updated

February 21, 2021

Results First Posted

February 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

US(4)