InsomniaPhase 3NCT00561821
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
A Phase 3 study testing Esmirtazapine in people with Insomnia and Sleep Initiation and Maintenance Disorders, run by Merck Sharp & Dohme LLC.
Trial summary
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants with chronic primary insomnia. Primary efficacy variable is Wake time After Sleep Onset (WASO), averaged over all in-treatment time points and measured by polysomnography (PSG). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia, Sleep Initiation and Maintenance Disorders, Mental Disorders
- What is being tested?
- Esmirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 538 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2007to 21 Dec 2009
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- are at least 65 years of age at screening;
- sign written informed consent after the scope and
- nature of the investigation have been explained to
- them, before screening evaluations;
- are able to speak, read and understand the language of
- the investigator, study staff (including raters) and the
Show all 28Show fewer
- informed consent form, and possess the ability to
- respond to questions, follow instructions and complete
- questionnaires;
- have demonstrated capability to independently
- complete the LogPad questionnaires and have
- completed the questionnaires at least 6 out of 7 days of
- the week preceding randomization;
- have a regular sleep pattern, meaning bedtime regularly
- occurs between 2100 hours and 2400 hours, with no more variation
- from these boundaries than 2 times/ week, with 5-8.5
- hours in bed;
- have a documented diagnosis of chronic primary
- insomnia, defined as fulfillment of the Diagnostic and Statistical Manual of Mental Disorders IV - Text Revision (DSM-IV-TR) criteria
- for primary insomnia (DSM-IV-TR 307.42) with a duration
- of >= 1 month; fulfill the following PSG criteria on the
- two screening/baseline PSG nights:
- average Total Sleep Time (TST) < 6.5 h (and each night greater than or
- equal to 3 h and < 7 h),
- average WASO greater than or equal to 45 minutes
- (and each night greater than or equal to 30 min),
- average Latency to Persistent Sleep (LPS) 15 min (and each night greater than or
- equal to 10 min).
Who cannot join
- have other sleep disorders (DSM-IV-TR), such as sleep
- related breathing disorders Apnea-Hypopnea Index (AHI) greater than or equal
- to 15), Periodic Leg Movements with Arousals Index (PLMAI)
- greater than or equal to 10), restless leg syndrome,
- narcolepsy, circadian sleep wake rhythm disorders,
- Rapid Eye Movement (REM) behavioral disorder or any parasomnia;
Show all 38Show fewer
- have any significant medical or DSM-IV-TR
- psychiatric illness causing the sleep disturbances;
- currently meet diagnostic criteria for DSM-IV-TR
- depression Major Depressive Disorder (MDD) or have been diagnosed and treated
- for MDD within the last 2 years;
- have a history of bipolar disorder, a history of suicide attempt or a family history of suicide. A family history of suicide is defined as any history of suicide in the first and second degree family (parents, siblings, grandparents, or offspring), or a pattern of completed suicides (more than one) in the third degree family (aunts, uncles, nieces and nephews);
- have a history or signs of dementia or other serious
- cognitive impairment, as defined by a score of less than
- 26 on the Mini-Mental State Examination;
- have a significant, unstable medical illness e.g. acute or
- chronic pain, hepatic, renal, metabolic or cardiac
- disease;
- had serious head injury or stroke within the past year,
- or a history of (non-febrile) seizures;
- have clinically relevant electrocardiogram (ECG) abnormalities at
- screening, as judged by the investigator;
- have clinically relevant abnormal hematology or
- biochemistry values at screening, as judged by the
- investigator;
- have DSM-IV-TR substance abuse or DSM-IV-TR
- addiction within the last year;
- drink more than 2 alcoholic drinks in a day. One drink is approximately equal to: 12 oz or 360 ml of beer (regular or light), or 4 oz or 120 ml of red or white wine, or 2 oz or 60 ml of desert wine (e.g. port, sherry), or 12 oz or 360 ml of wine cooler (regular or light), or 1 oz or 30 ml or spirits (80 to 100 proof, e.g. whiskey, vodka);
- are routinely sleeping during daytime (napping) for more than 20 minutes per day, 3 days or more per week;
- are night workers or rotating shift workers currently, or in the past 6 months
- use of psychotropic drugs affecting sleep within two weeks prior to randomization (fluoxetine: five weeks);
- use of concomitant medication affecting sleep (e.g. anxiolytics, sedatives, antidepressants, antipsychotics, centrally active sedating antihistamines, central nervous system (CNS)
- stimulants, alpha-2-antagonists, respiratory stimulants and decongestants);
- smoke > 15 cigarettes per day and/or can not abstain from smoking during the night;
- drink excessive amounts of caffeinated beverages/day (more than 500 mg caffeine per day);
- have a body mass index (BMI) >= 36;
- have a positive urine drug screen at screening or at baseline;
- have a known hypersensitivity to mirtazapine or to any of the excipients;
About this study
Official title: A Double-Blind, Randomized, Parallel Group, Placebo- Controlled Sleep Laboratory Efficacy and Safety Study With Org 50081 in Elderly Subjects With Chronic Primary Insomnia
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)
compared to placebo in elderly participants with chronic primary
insomnia. Primary efficacy variable is Wake time After Sleep
Onset (WASO), averaged over all in-treatment time points
and measured by polysomnography (PSG).
Read the detailed description
Insomnia is a common complaint or disorder throughout the
world. About one third of the population in the industrial
countries reports difficulty initiating or maintaining sleep,
resulting in a non-refreshing or non-restorative sleep. The
majority of the insomniacs suffer chronically from their
complaints.
The maleic acid salt of Org 4420, code name Org 50081, known as Esmirtazapine, was
selected for development in the treatment of insomnia. The
first clinical trial with Esmirtazapine was a proof-of-concept trial
with a four-way cross-over design. All 3 Esmirtazapine dose
groups showed a statistically significant positive effect on
TST (objective and subjective) and WASO, as compared to
placebo.
The current study is designed to assess the efficacy and safety
of Esmirtazapine in a double-blind, placebo-controlled, parallel,
randomized trial in elderly participants suffering from chronic
primary insomnia.
- Conditions
- Insomnia, Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders
- Being tested
- Esmirtazapine, Placebo
- Keywords
- elderly, randomized, placebo controlled
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmirtazapineDrug
one tablet daily
PlaceboDrug
one tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Esmirtazapine 0.5 mg | Experimental | one placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days Receives: Drug: Esmirtazapine; Drug: Placebo |
| Esmirtazapine 1.5 mg | Experimental | one placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days Receives: Drug: Esmirtazapine; Drug: Placebo |
| Esmirtazapine 3.0 mg | Experimental | one placebo tablet daily for 14 days, followed by one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days Receives: Drug: Esmirtazapine; Drug: Placebo |
| Placebo | Placebo comparator | one placebo tablet daily for 14 days, followed by one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Wake Time After Sleep Onset Measured by Polysomnography
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Secondary outcomes (16)
Average Latency to Persistent Sleep Measured by Polysomnography
Latency to Persistent Sleep (LPS) is the time from lights out to the first 20 consecutive epochs scored as sleep by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of LPS (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Average Total Sleep Time Measured by Polysomnography
Total sleep time (TST) is the sleep time recorded by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of TST (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Average Number of Awakenings Measured by Polysomnography
Number of awakenings (NAW) was measured by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of NAW (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the first quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the second quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the third quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the fourth quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography
Number of stage shifts to stage 1 of sleep or to awaken was measured by PSG. A stage shift is the transition measured by PSG between various sleep stages. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of the number of stage shifts (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Measured: Up to Day 16
Average Subjective Total Sleep Time Based on Sleep Diary
Total Sleep Time (TST) is a subjective time (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.
Measured: Up to Day 16
Average Subjective Sleep Latency Based on Sleep Diary
Sleep latency (SL) is the time taken to fall asleep (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.
Measured: Up to Day 16
Average Subjective Number of Awakenings Based on Sleep Diary
Number of awakenings between sleep onset and final awakening (NAW) is a subjective number (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.
Measured: Up to Day 16
Average Subjective Wake Time After Sleep Onset Based on Sleep Diary
Wake Time after Sleep Onset (WASO) is after falling asleep initially, the subjective time that the participant was awake during the night. Daily recordings by the participant in an electronic diary (observed data only), were averaged over the entire 16-day, double-blind treatment period.
Measured: Up to Day 16
Average Subjective Quality of Sleep Based on Sleep Diary
Quality of Sleep (QS) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.
Measured: Up to Day 16
Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary
Satisfaction of Sleep Duration (SSD) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.
Measured: Up to Day 16
Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period
An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.
Measured: Up to Day 16
Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period
An AE is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.
Measured: Up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study start20 Nov 2007
- Primary completion21 Dec 2009
- Study completion21 Dec 2009
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 InsomniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561821
- Sponsor's protocol ID
- P05709
- Other IDs
- 21108, MK-8265-006
- Status last verified
- Sep 2018
- First submitted
- 19 Nov 2007
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel Group, Placebo- Controlled Sleep Laboratory Efficacy and Safety Study With Org 50081 in Elderly Subjects With Chronic Primary Insomnia
- ClinicalTrials.gov ID
- NCT00561821
- Acronym / sponsor ID
- P05709
- Conditions
- Insomnia, Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders
- Keywords
- elderly, randomized, placebo controlled
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2007 (actual)
- Primary completion
- 21 Dec 2009 (actual)
- Study completion
- 21 Dec 2009 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Posted 5 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)
compared to placebo in elderly participants with chronic primary
insomnia. Primary efficacy variable is Wake time After Sleep
Onset (WASO), averaged over all in-treatment time points
and measured by polysomnography (PSG).
Detailed description
Insomnia is a common complaint or disorder throughout the
world. About one third of the population in the industrial
countries reports difficulty initiating or maintaining sleep,
resulting in a non-refreshing or non-restorative sleep. The
majority of the insomniacs suffer chronically from their
complaints.
The maleic acid salt of Org 4420, code name Org 50081, known as Esmirtazapine, was
selected for development in the treatment of insomnia. The
first clinical trial with Esmirtazapine was a proof-of-concept trial
with a four-way cross-over design. All 3 Esmirtazapine dose
groups showed a statistically significant positive effect on
TST (objective and subjective) and WASO, as compared to
placebo.
The current study is designed to assess the efficacy and safety
of Esmirtazapine in a double-blind, placebo-controlled, parallel,
randomized trial in elderly participants suffering from chronic
primary insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Esmirtazapine 0.5 mg | Experimental | Drug: Esmirtazapine, Drug: Placeboone placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| Esmirtazapine 1.5 mg | Experimental | Drug: Esmirtazapine, Drug: Placeboone placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| Esmirtazapine 3.0 mg | Experimental | Drug: Esmirtazapine, Drug: Placeboone placebo tablet daily for 14 days, followed by one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days |
| Placebo | Placebo comparator | Drug: Placeboone placebo tablet daily for 14 days, followed by one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (28 listed)
- are at least 65 years of age at screening;
- sign written informed consent after the scope and
- nature of the investigation have been explained to
- them, before screening evaluations;
- are able to speak, read and understand the language of
Key exclusion criteria (38 listed)
- have other sleep disorders (DSM-IV-TR), such as sleep
- related breathing disorders Apnea-Hypopnea Index (AHI) greater than or equal
- to 15), Periodic Leg Movements with Arousals Index (PLMAI)
- greater than or equal to 10), restless leg syndrome,
- narcolepsy, circadian sleep wake rhythm disorders,
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 |
|---|---|---|
| Esmirtazapineone tablet daily | Drug | Esmirtazapine 0.5 mg, Esmirtazapine 1.5 mg, Esmirtazapine 3.0 mg |
| Placeboone tablet daily | Drug | Esmirtazapine 0.5 mg, Esmirtazapine 1.5 mg, Esmirtazapine 3.0 mg, Placebo |
Primary outcome
Average Wake Time After Sleep Onset Measured by Polysomnography
Time frame: Up to Day 16
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
16 secondary outcomes
Average Latency to Persistent Sleep Measured by Polysomnography
Time frame: Up to Day 16
Average Total Sleep Time Measured by Polysomnography
Time frame: Up to Day 16
Average Number of Awakenings Measured by Polysomnography
Time frame: Up to Day 16
Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography
Time frame: Up to Day 16
Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography
Time frame: Up to Day 16
Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography
Time frame: Up to Day 16
Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography
Time frame: Up to Day 16
Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography
Time frame: Up to Day 16
Average Subjective Total Sleep Time Based on Sleep Diary
Time frame: Up to Day 16
Average Subjective Sleep Latency Based on Sleep Diary
Time frame: Up to Day 16
Average Subjective Number of Awakenings Based on Sleep Diary
Time frame: Up to Day 16
Average Subjective Wake Time After Sleep Onset Based on Sleep Diary
Time frame: Up to Day 16
Average Subjective Quality of Sleep Based on Sleep Diary
Time frame: Up to Day 16
Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary
Time frame: Up to Day 16
Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period
Time frame: Up to Day 16
Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period
Time frame: Up to Day 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esmirtazapine in people with Insomnia and Sleep Initiation and Maintenance 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 28 inclusion and 38 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 3 Oct 2018. 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 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 Aug 2014). 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?
Average Wake Time After Sleep Onset Measured by Polysomnography (time frame: Up to Day 16). 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 3 Oct 2018.