Trial · NCT00631657
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
NCT00631657, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2014-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002). Trials, record NCT00631657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00631657
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
- NCT number
- NCT00631657
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 460 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders, Sleep Disorder, Intrinsic
- Interventions
- Esmirtazapine, Placebo
- First posted
- 2008-03-10
- Last updated
- 2018-10-02
- Other registries' IDs
- eudract:2007-005236-92
- Results first posted
- 2014-08-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | TST was defined as the time recorded for sleep diary question 6 "How much time did you actually spend sleeping?" as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach. |
| Secondary | Number of Participants Who Experienced Adverse Events (AEs) | Up to 31 weeks | An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period. |
| Secondary | Number of Participants Who Discontinued Study Drug Due to an AE | Up to 27 weeks | An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period. |
| Secondary | Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | SL was defined as the time recorded for sleep diary question 3 "How long did it take you to fall asllep?", as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach. |
| Secondary | Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | WASO was defined as the time recorded for sleep diary question 5 "How much time were you awake, after falling asleep initially?", as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach. |
| Other | Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | NAW was defined as the number of times recorded for sleep diary question 4a "How many times did you wake up during the night?", as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach. |
| Other | Change From Baseline in Sleep Quality - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 "Rate the quality of your sleep last night", as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach. |
| Other | Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 "How satisfied are you about your sleep duration of last night?", as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach. |
| Other | Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period | Baseline and Week 26 | SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization. |
| Other | Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period | Baseline and Week 26 | The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline TST efficacy assessment. | minutes | MEAN |
| SECONDARY | Number of Participants Who Experienced Adverse Events (AEs) | Up to 31 weeks | The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued Study Drug Due to an AE | Up to 27 weeks | The AST population consisted of all participants who received at least one dose of any study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline SL efficacy assessment. | minutes | MEAN |
| SECONDARY | Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline WASO efficacy assessment. | minutes | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline NAW efficacy assessment. | number of awakenings | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Sleep Quality - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Sleep Quality efficacy assessment. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period | Baseline and the Mean of Weeks 14-26 | The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Satisfaction with Sleep Duration efficacy assessment. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period | Baseline and Week 26 | The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 SF-36 efficacy assessment. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period | Baseline and Week 26 | The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 IGR efficacy assessment. | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period | Esmirtazapine 4.5 mg | 65.9 | Standard Deviation 71.9 | minutes | |
| Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period | Placebo | 19.3 | Standard Deviation 62.1 | minutes | |
| Number of Participants Who Experienced Adverse Events (AEs) | Esmirtazapine 4.5 mg | 253 | participants | ||
| Number of Participants Who Experienced Adverse Events (AEs) | Placebo | 75 | participants | ||
| Number of Participants Who Discontinued Study Drug Due to an AE | Esmirtazapine 4.5 mg | 47 | participants | ||
| Number of Participants Who Discontinued Study Drug Due to an AE | Placebo | 7 | participants | ||
| Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period | Esmirtazapine 4.5 mg | -29.7 | Standard Deviation 47.3 | minutes | |
| Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period | Placebo | -26.9 | Standard Deviation 46.8 | minutes | |
| Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period | Esmirtazapine 4.5 mg | -46.4 | Standard Deviation 57.7 | minutes | |
| Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period | Placebo | -20.8 | Standard Deviation 51.4 | minutes |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 6-Month Treatment Period | STARTED | Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg | 344 | |
| 6-Month Treatment Period | STARTED | Esmirtazapine 4.5 mg/Placebo | 0 | |
| 6-Month Treatment Period | STARTED | Placebo/Placebo | 116 | |
| 6-Month Treatment Period | Treated | Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg | 342 | |
| 6-Month Treatment Period | Treated | Esmirtazapine 4.5 mg/Placebo | 0 | |
| 6-Month Treatment Period | Treated | Placebo/Placebo | 115 | |
| 6-Month Treatment Period | COMPLETED | Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg | 203 | |
| 6-Month Treatment Period | COMPLETED | Esmirtazapine 4.5 mg/Placebo | 0 | |
| 6-Month Treatment Period | COMPLETED | Placebo/Placebo | 66 | |
| 6-Month Treatment Period | NOT COMPLETED | Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg | 141 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Esmirtazapine 4.5 mg | 20 | 342 | 21 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 5 | 115 | 5 |
| other | Fatigue | General disorders | Esmirtazapine 4.5 mg | 18 | 342 | 20 |
| other | Fatigue | General disorders | Placebo | 7 | 115 | 7 |
| other | Nasopharyngitis | Infections and infestations | Esmirtazapine 4.5 mg | 35 | 342 | 42 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 14 | 115 | 17 |
| other | Weight increased | Investigations | Esmirtazapine 4.5 mg | 58 | 342 | 63 |
| other | Weight increased | Investigations | Placebo | 4 | 115 | 4 |
| other | Increased appetite | Metabolism and nutrition disorders | Esmirtazapine 4.5 mg | 34 | 342 | 37 |
| other | Increased appetite | Metabolism and nutrition disorders | Placebo | 1 | 115 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esmirtazapine 4.5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Esmirtazapine 4.5 mg | 183 | 342 |
| Total, other adverse events | Placebo | 40 | 115 |
| Total, serious adverse events | Esmirtazapine 4.5 mg | 8 | 342 |
| Total, serious adverse events | Placebo | 2 | 115 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32351205 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esmirtazapine 4.5 mg vs Placebo: Number of Participants Who Experienced Adverse Events (AEs) | Trial comparisons |
| Esmirtazapine 4.5 mg vs Placebo: Number of Participants Who Discontinued Study Drug Due to an AE | Trial comparisons |
| Esmirtazapine 4.5 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00631657
GET https://conductscience.org/api/trials/v1/NCT00631657/results?page=2