InsomniaPhase 1NCT01106859

Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet

A Phase 1 study testing zopiclone and zolpidem tartrate sublingual tablet in people with Insomnia, run by Transcept Pharmaceuticals at 1 site in Netherlands.

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

A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The next morning driving performance will be measured by taking a standardized driving test. Read more about this study

Who is it for?: Ages 21 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Insomnia
What is being tested?: zopiclone and zolpidem tartrate sublingual tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteNetherlands
Study dates: Jun 2010to Sep 2010
Phase: Phase 1
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 21 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects between the ages of 21 and 64 inclusive. For female subjects only: Female subjects will be included if they are post-menopausal or sterilized, or if they are of childbearing potential, they are not breastfeeding, their pregnancy test is negative, they have no intention of becoming pregnant during the course of the study, and are using adequate contraceptive drugs or devices. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization or abstinence. Females using oral contraception must have started using the medication at least 4 weeks prior to screening. Surgical sterilization must have occurred at least 6 weeks prior to screening.
Good health on the basis of pre-study history and physical examination, vital signs and the results of blood chemistry, hematology, and urinalysis
Good binocular visual acuity, corrected or uncorrected
Possession of valid driver's license for 3 years or more
Driving experience at least 3000 km/year
Signed informed consent

Who cannot join

A history of drug addiction or drug or substance abuse, including alcohol abuse, within the past 12 months
Has a history of restless legs syndrome, sleep apnea, narcolepsy or other primary sleep disorder
A known hypersensitivity to zolpidem or zopiclone
Has undergone oral surgery, tooth extraction or piercing of the lip/tongue within 60 days prior to screening
Has used any medication to promote sleep, including herbal medications, within 14 days (or 5 half-lives of the drug, whichever is longer) prior to screening
Prescription medications for other health conditions are allowed as long as the subject has been on a stable dose at least 30 days prior to screening

Show all 18Show fewer

Has taken any drugs known to induce hepatic drug metabolism (i.e., rifampin) within 30 days prior to screening
BMI > 29 Kg/M^2
Current use of medication that affects driving performance
Smokes more than 10 cigarettes/day
Uses tobacco products during periods of nighttime awakening
Consumes more than 6 cups of coffee/day
Consumes more than 21 glasses of alcohol/week
Has received an investigational drug within 60 days or 5 half-lives (whichever is longer) prior to screening
Has any additional condition(s) that in the Investigator's opinion would:
Affect sleep/wake function
Prohibit the subject from completing the study
Not be in the best interest of the subject to participate in the study

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Maastricht University
Maastricht, 6229 ER

Other trials in Netherlands

About this study

Official title: Assessment of Next-Morning Driving Performance After Middle of the Night Administration of Zolpidem Tartrate Sublingual Tablet 3.5 mg in Healthy Adult Volunteers: Single-center, Double-blind, Randomized, Placebo-controlled, Four-way Crossover Study

Conditions: Insomnia
Being tested: zopiclone, zolpidem tartrate sublingual tablet, Placebo (sublingual tablet), Placebo
Keywords: insomnia
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.

zopicloneDrug
Also called non-benzodiazepine hypnotic agent, Zimovane, Imovane
7.5 mg tablet by mouth. Zopiclone is a commonly used hypnotic in Europe that is known to impair driving in the morning 9 hours after dosing.
zolpidem tartrate sublingual tabletDrug
Also called Intermezzo®
3.5 mg zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Placebo (sublingual tablet)Drug
Placebo matching zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
PlaceboDrug
Placebo matching zopiclone

Study groups in NCT01106859
Study group	Role	What they receive
zopiclone	Active comparator	Zopiclone is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet. Receives: Drug: zopiclone; Drug: Placebo (sublingual tablet)
zolpidem 3 hours prior	Experimental	A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving. Receives: Drug: zolpidem tartrate sublingual tablet; Drug: Placebo
zolpidem 4 hours prior	Experimental	A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 4 hours prior to driving. Receives: Drug: zolpidem tartrate sublingual tablet; Drug: Placebo
Placebo	Placebo comparator	A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet. Receives: Drug: Placebo (sublingual tablet); Drug: Placebo

What is being measured

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

Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold
SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.5 cm and <= -2.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.5 cm, and an improved performance is when the difference of SDLP < -2.5 cm.
Measured: 3-9 hours post dose
Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.
A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance.
Measured: 3-9 hours post dose

Secondary outcomes (7)

Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test
Standard deviation of lateral position (SDLP) in a highway-driving lane is a surrogate measure for driving performance. It measures the driver's ability to stay in a constant position within the driving lane. Variations in the lateral position are recorded and analyzed.
Measured: 3-9 hours post dose
Mean Standard Deviation of Speed (SDS) in the Highway Drive Test
Mean standard deviation of speed (SDS) is a common measure of the driver's ability to maintain a constant driving speed. Variations in driving speed are recorded and analyzed.
Measured: 3-9 hours post dose
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs)
Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness (summarized as 'unrelated' and 'related') to study treatment. Also included are counts of participants with serious AEs, AEs leading to discontinuation of study treatment, and deaths.
Measured: Day 1 -6 weeks
Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.0 cm SDLP Threshold
SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.0 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.0 cm and <= -2.0 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.0 cm, and an improved performance is when the difference of SDLP < -2.0 cm.
Measured: 3-9 hours post dose
Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.
A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance.
Measured: 3-9 hours post dose
Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 3.5 cm SDLP Threshold
SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 3.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 3.5 cm and <= -3.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 3.5 cm, and an improved performance is when the difference of SDLP < -3.5 cm.
Measured: 3-9 hours post dose
Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.
A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance.
Measured: 3-9 hours post dose

Timeline

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

Jun 2010Sep 2010

First posted20 Apr 2010 (estimated)
Study startJun 2010
Primary completionSep 2010
Study completionSep 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01106859
Sponsor's protocol ID: ZI-18
Other IDs: 2010-019959-22
Status last verified: Feb 2012
First submitted: 16 Apr 2010
Last updated: 14 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vermeeren A, Vuurman EF, Leufkens TR, Van Leeuwen CJ, Van Oers AC, Laska E, Rico S, Steinberg F, Roth T. Residual effects of low-dose sublingual zolpidem on highway driving performance the morning after middle-of-the-night use. Sleep. 2014 Mar 1;37(3):489-96. doi: 10.5665/sleep.3482.
PubMed 24587571

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?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Next-Morning Driving Performance After Middle of the Night Administration of Zolpidem Tartrate Sublingual Tablet 3.5 mg in Healthy Adult Volunteers: Single-center, Double-blind, Randomized, Placebo-controlled, Four-way Crossover Study
ClinicalTrials.gov ID: NCT01106859
Acronym / sponsor ID: ZI-18
Conditions: Insomnia
Keywords: insomnia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Transcept PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 20 Apr 2010 (estimated)
Results: Posted 20 Jan 2012

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
zopiclone	Active comparator	Drug: zopiclone, Drug: Placebo (sublingual tablet)Zopiclone is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
zolpidem 3 hours prior	Experimental	Drug: zolpidem tartrate sublingual tablet, Drug: PlaceboA placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
zolpidem 4 hours prior	Experimental	Drug: zolpidem tartrate sublingual tablet, Drug: PlaceboA placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
Placebo	Placebo comparator	Drug: Placebo (sublingual tablet), Drug: PlaceboA placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.

Who may qualify

Ages: 21 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male or female subjects between the ages of 21 and 64 inclusive. For female subjects only: Female subjects will be included if they are post-menopausal or sterilized, or if they are of childbearing potential, they are not breastfeeding, their pregnancy test is negative, they have no intention of becoming pregnant during the course of the study, and are using adequate contraceptive drugs or devices. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization or abstinence. Females using oral contraception must have started using the medication at least 4 weeks prior to screening. Surgical sterilization must have occurred at least 6 weeks prior to screening.
Good health on the basis of pre-study history and physical examination, vital signs and the results of blood chemistry, hematology, and urinalysis
Good binocular visual acuity, corrected or uncorrected
Possession of valid driver's license for 3 years or more
Driving experience at least 3000 km/year

Key exclusion criteria (18 listed)

A history of drug addiction or drug or substance abuse, including alcohol abuse, within the past 12 months
Has a history of restless legs syndrome, sleep apnea, narcolepsy or other primary sleep disorder
A known hypersensitivity to zolpidem or zopiclone
Has undergone oral surgery, tooth extraction or piercing of the lip/tongue within 60 days prior to screening
Has used any medication to promote sleep, including herbal medications, within 14 days (or 5 half-lives of the drug, whichever is longer) prior to screening

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
zopicloneAlso: non-benzodiazepine hypnotic agent, Zimovane, Imovane7.5 mg tablet by mouth. Zopiclone is a commonly used hypnotic in Europe that is known to impair driving in the morning 9 hours after dosing.	Drug	zopiclone
zolpidem tartrate sublingual tabletAlso: Intermezzo®3.5 mg zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.	Drug	zolpidem 3 hours prior, zolpidem 4 hours prior
Placebo (sublingual tablet)Placebo matching zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.	Drug	Placebo, zopiclone
PlaceboPlacebo matching zopiclone	Drug	Placebo, zolpidem 3 hours prior, zolpidem 4 hours prior

Primary outcome

Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold
Time frame: 3-9 hours post dose
SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.5 cm and <= -2.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.5 cm, and an improved performance is when the difference of SDLP < -2.5 cm.
Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
Time frame: 3-9 hours post dose
This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000. A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance.

7 secondary outcomes

Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test
Time frame: 3-9 hours post dose
Mean Standard Deviation of Speed (SDS) in the Highway Drive Test
Time frame: 3-9 hours post dose
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs)
Time frame: Day 1 -6 weeks
Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.0 cm SDLP Threshold
Time frame: 3-9 hours post dose
Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
Time frame: 3-9 hours post dose
Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 3.5 cm SDLP Threshold
Time frame: 3-9 hours post dose
Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
Time frame: 3-9 hours post dose

Results and safety

Results posted to the registry on 20 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Population	40	40

Primary outcome: Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold

Time frame: 3-9 hours post dose. Number. Unit: participants

Measure	Zolpidem 4 Hours Prior n = 40	Zolpidem 3 Hours Prior n = 40	Zopiclone n = 40
Impaired	5	10	18
Neutral	34	29	22
Improved	1	1	0

Population analysed: Intent to treat population

Primary outcome: Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy

Time frame: 3-9 hours post dose. Number. Unit: proportion

Measure	Zolpidem 4 Hours Prior n = 40	Zolpidem 3 Hours Prior n = 40	Zopiclone n = 40	Placebo n = 40
Probability - impaired	0.125	0.250	0.450	NA
Probability - improved	0.025	0.025	0.000	NA

Zolpidem 4 Hours Prior vs Placebo: p = 0.2188, McNemar
Zolpidem 3 Hours Prior vs Placebo: p = 0.0117, McNemar
Zopiclone vs Placebo: p <0.0001, McNemar

Population analysed: Intent to treat population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent AEs (Day 1 to Week 6). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zolpidem 4 Hours Prior	0 of 40 (0%)	5 of 40 (12.5%)	Not reported
Zolpidem 3 Hours Prior	0 of 40 (0%)	5 of 40 (12.5%)	Not reported
Zopiclone	0 of 40 (0%)	6 of 40 (15%)	Not reported
Placebo	0 of 40 (0%)	4 of 40 (10%)	Not reported

Limitations and caveats (from the sponsor): No studies directly connect SDLP thresholds with an increased risk of an accident for an individual. Nor has a SDLP threshold been adopted by a regulatory body. Based on published literature, an SDLP change of 2.5 cm was used in the primary outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24587571Vermeeren A, Vuurman EF, Leufkens TR, Van Leeuwen CJ, Van Oers AC, Laska E, Rico S, Steinberg F, Roth T. Residual effects of low-dose sublingual zolpidem on highway driving performance the morning after middle-of-the-night use. Sleep. 2014 Mar 1;37(3):489-96. doi: 10.5665/sleep.3482.

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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.

Annemiek Vermeeren, PhD principal investigator

Maastricht University

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing zopiclone and zolpidem tartrate sublingual tablet in people with Insomnia, run by Transcept Pharmaceuticals at 1 site in Netherlands.

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 6 inclusion and 18 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 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 20 Jan 2012). 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?

Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold (time frame: 3-9 hours post dose). The study lists 2 primary outcomes in all. 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 NCT01106859, which also lists 1 linked publication.

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 14 Feb 2012.