InsomniaPhase 3NCT00610675
Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)
A Phase 3 study testing Org 50081 in people with Insomnia, run by Merck Sharp & Dohme LLC.
Trial summary
This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Org 50081
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2006to 17 Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
- completed Protocol P05706 or P05707;
- Have safety and efficacy assessments conducted per protocol P05706 or P05707.
Who cannot join
- clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
- clinically relevant abnormal laboratory values as judged by the investigator;
- any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
- were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.
About this study
Official title: Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 176001 or 176002.
This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.
- Conditions
- Insomnia
- Being tested
- Org 50081
- Keywords
- Fifty two weeks, Open label, extension
- 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.
Org 50081Drug
One tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Esmirtazapine | Experimental | One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks Receives: Drug: Org 50081 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Adverse Event
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 57 weeks
Number of Participants Who Discontinued Treatment Due to an Adverse Event
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 IMP, whether or not it is related to the IMP.
Measured: Up to 52 weeks
Secondary outcomes (6)
Change From Baseline in Total Sleep Time at Week 52
Total Sleep Time (TST) is a subjective time recorded by the participant in an electronic sleep diary in response to the question "How much time did you actually spend sleeping?". Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the last observation carried forward (LOCF) method, where the last available assessments prior to the scheduled observation were averaged.
Measured: Baseline and Week 52
Change From Baseline in Sleep Latency at Week 52
Sleep Latency (SL) is the time from when the participant went to bed up to the the time the participant actually fell asleep, recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.
Measured: Baseline and Week 52
Change From Baseline in Wake Time After Sleep Onset at Week 52
Wake time after sleep onset (WASO) is, if the planned waking time is on or after the time of final awakening, as follows: total time from falling asleep to the time of planned wake up minus the total sleep time. If the planned waking time is before the time of final awakening then WASO is as follows: total time from falling asleep to the time of actual final awakening minus the total sleep time. All times were recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.
Measured: Baseline and Week 52
Change From Baseline in Number of Awakenings at Week 52
Number of awakenings is a subjective number recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.
Measured: Baseline and Week 52
Change From Baseline in Quality of Sleep Scale at Week 52
Quality of Sleep is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.
Measured: Baseline and Week 52
Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52
Satisfaction with Sleep Duration is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study start7 Dec 2006
- Primary completion17 Aug 2009
- Study completion17 Aug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 346 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
- NCT00610675
- Sponsor's protocol ID
- P05708
- Other IDs
- 176004
- Status last verified
- Sep 2018
- First submitted
- 9 Jan 2008
- 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
- Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 176001 or 176002.
- ClinicalTrials.gov ID
- NCT00610675
- Acronym / sponsor ID
- P05708
- Conditions
- Insomnia
- Keywords
- Fifty two weeks, Open label, extension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2006 (actual)
- Primary completion
- 17 Aug 2009 (actual)
- Study completion
- 17 Aug 2009 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 30 Jul 2014
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 a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esmirtazapine | Experimental | Drug: Org 50081One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
- completed Protocol P05706 or P05707;
- Have safety and efficacy assessments conducted per protocol P05706 or P05707.
Key exclusion criteria (4 listed)
- clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
- clinically relevant abnormal laboratory values as judged by the investigator;
- any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
- were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.
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 50081One tablet daily | Drug | Esmirtazapine |
Primary outcome
Number of Participants With an Adverse Event
Time frame: Up to 57 weeks
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.
Number of Participants Who Discontinued Treatment Due to an Adverse Event
Time frame: Up to 52 weeks
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 IMP, whether or not it is related to the IMP.
6 secondary outcomes
Change From Baseline in Total Sleep Time at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Sleep Latency at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Wake Time After Sleep Onset at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Number of Awakenings at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Quality of Sleep Scale at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52
Time frame: Baseline and Week 52
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 Org 50081 in people with Insomnia, 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 3 inclusion and 4 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. 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 30 Jul 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?
Number of Participants With an Adverse Event (time frame: Up to 57 weeks). 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?
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.