Sleep Initiation and Maintenance DisordersPhase 1NCT00798395
A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)
A Phase 1 study testing Org 50081 and zopiclone in people with Sleep Initiation and Maintenance Disorders and Mental Disorders, run by Merck Sharp & Dohme LLC.
Trial summary
This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Mental Disorders
- What is being tested?
- Org 50081 and zopiclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has at least 3 years of car driving experience
- Subject signs the trial Informed Consent Form
- Subject is in a healthy condition as judged by the investigator
- Subject has a regular sleep pattern
Who cannot join
- Subject has insomnia or any other sleep disorder
- Medication or drug use of any kind prior to the study
- Relevant history or presence of a significant medical illness
About this study
Official title: A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.
This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.
- Being tested
- Org 50081, Placebo, zopiclone
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Org 50081Drug
1.5 mg on day 1-7
Org 50081Drug
4.5 mg on Day 1-7
PlaceboDrug
Once daily on Day 1-7
zopicloneDrug
Single dose of 7.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Not described Receives: Drug: Org 50081 |
| Treatment 2 | Experimental | Not described Receives: Drug: Org 50081 |
| Treatment 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| Treatment 4 | Active comparator | Not described Receives: Drug: zopiclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Standard Deviation of Lateral Position
Measured: Day 8
Secondary outcomes (1)
Psychomotor and cognitive performance tasks
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798395
- Sponsor's protocol ID
- P05794
- Other IDs
- 21105
- Status last verified
- Oct 2015
- First submitted
- 25 Nov 2008
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00798395
- Acronym / sponsor ID
- P05794
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: Org 50081 |
| Treatment 2 | Experimental | Drug: Org 50081 |
| Treatment 3 | Placebo comparator | Drug: Placebo |
| Treatment 4 | Active comparator | Drug: zopiclone |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject has at least 3 years of car driving experience
- Subject signs the trial Informed Consent Form
- Subject is in a healthy condition as judged by the investigator
- Subject has a regular sleep pattern
Key exclusion criteria (3 listed)
- Subject has insomnia or any other sleep disorder
- Medication or drug use of any kind prior to the study
- Relevant history or presence of a significant medical illness
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 |
|---|---|---|
| Org 500811.5 mg on day 1-7 | Drug | Treatment 1 |
| Org 500814.5 mg on Day 1-7 | Drug | Treatment 2 |
| PlaceboOnce daily on Day 1-7 | Drug | Treatment 3 |
| zopicloneSingle dose of 7.5 mg | Drug | Treatment 4 |
Primary outcome
The Standard Deviation of Lateral Position
Time frame: Day 8
1 secondary outcome
Psychomotor and cognitive performance tasks
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Org 50081 and zopiclone in people with Sleep Initiation and Maintenance Disorders and Mental Disorders, run by Merck Sharp & Dohme LLC.
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 4 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Standard Deviation of Lateral Position (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2015.