HealthyPhase 3NCT01888497

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

A Phase 3 study testing Gabapentin, Diphenhydramine citrate and Triazolam in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Gabapentin, Diphenhydramine citrate and Triazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 59 participants
Where: 4 sitesUnited States
Study dates: 29 Jul 2013to 14 Dec 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

NeuroTrials Research Sleep Lab
Atlanta, Georgia, 30342
NeuroTrials Research, Inc.
Atlanta, Georgia, 30342
Baptist Sleep Centers, LLP
South Miami, Florida, 33143
Miami Research Associates
South Miami, Florida, 33143

Other trials in United States

About this study

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

Conditions: Healthy
Being tested: Gabapentin, Diphenhydramine citrate, Triazolam, Placebo
Keywords: Sleeplessness
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GabapentinDrug
250 mg, oral, prior to bedtime on the night before performance testing
Diphenhydramine citrateDrug
76 mg, oral, prior to bedtime on the night before performance testing
TriazolamDrug
0.5 mg, oral, prior to bedtime on the night before performance testing
PlaceboDrug
Oral, prior to bedtime on the night before performance testing

Study groups in NCT01888497
Study group	Role	What they receive
Arm A	Experimental	Not described Receives: Drug: Gabapentin
Arm B	Experimental	Not described Receives: Drug: Diphenhydramine citrate
Arm C	Active comparator	Not described Receives: Drug: Triazolam
Arm D	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7.25 hours post-dose

Secondary outcomes (2)

Speed Deviation
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.
Measured: 7.25 hours post dose
Lane Exceedance
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.
Measured: 7.25 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 201314 Dec 2013

First posted27 Jun 2013 (estimated)
Study start29 Jul 2013
Primary completion14 Dec 2013
Study completion14 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01888497
Sponsor's protocol ID: A9451178
Status last verified: Jan 2021
First submitted: 25 Jun 2013
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01888497
Acronym / sponsor ID: A9451178
Conditions: Healthy
Keywords: Sleeplessness
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: 29 Jul 2013 (actual)
Primary completion: 14 Dec 2013 (actual)
Study completion: 14 Dec 2013 (actual)
First posted: 27 Jun 2013 (estimated)
Results: Posted 5 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Arm A	Experimental	Drug: Gabapentin
Arm B	Experimental	Drug: Diphenhydramine citrate
Arm C	Active comparator	Drug: Triazolam
Arm D	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gabapentin250 mg, oral, prior to bedtime on the night before performance testing	Drug	Arm A
Diphenhydramine citrate76 mg, oral, prior to bedtime on the night before performance testing	Drug	Arm B
Triazolam0.5 mg, oral, prior to bedtime on the night before performance testing	Drug	Arm C
PlaceboOral, prior to bedtime on the night before performance testing	Drug	Arm D

Primary outcome

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.

2 secondary outcomes

Speed Deviation
Time frame: 7.25 hours post dose
Lane Exceedance
Time frame: 7.25 hours post-dose

Results and safety

Results posted to the registry on 5 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diphenhydramine Citrate, Gabapentin, Placebo, Triazolam	13	13
Gabapentin, Triazolam, Diphenhydramine Citrate, Placebo	14	14
Triazolam, Placebo, Gabapentin, Diphenhydramine Citrate	15	15
Placebo, Diphenhydramine Citrate, Triazolam, Gabapentin	17	17

Primary outcome: Standard Deviation of Lateral Position (SDLP)

Time frame: 7.25 hours post-dose. Mean (Standard Deviation). Unit: centimeter (cm)

Measure	Placebo n = 58	Gabapentin n = 55	Diphenhydramine Citrate n = 57	Triazolam n = 56
Value	33.2 (8.0)	34.2 (10.0)	35.4 (8.9)	47.4 (12.0)

Placebo vs Triazolam: Hodges-Lehman estimate: 13.82 (95% CI 10.85 to 17.40), p <0.001, Wilcoxon Rank Sum test
Placebo vs Gabapentin: Hodges-Lehman estimate: 0.55 (95% CI -0.66 to 2.33)
Gabapentin vs Diphenhydramine Citrate: Hodges-Lehman estimate: 1.02 (95% CI -0.39 to 2.51), p = 0.134, Wilcoxon Rank Sum test

Population analysed: ITT population included all randomized participants who received at least 1 dose of investigational product and provided any data post-randomization.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 58 (0%)	3 of 58 (5.2%)	Not reported
Gabapentin	0 of 55 (0%)	2 of 55 (3.6%)	Not reported
Diphenhydramine Citrate	0 of 57 (0%)	3 of 57 (5.3%)	Not reported
Triazolam	0 of 56 (0%)	10 of 56 (17.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gabapentin, Diphenhydramine citrate and Triazolam in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standard Deviation of Lateral Position (SDLP) (time frame: 7.25 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01888497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.