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| ID | Type | Description | Link |
|---|---|---|---|
| 176002 | Other Identifier | Organon |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
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. It has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esmirtazapine 3.0 mg | Experimental | Participants took placebo tablets on Days -7 and -6, esmirtazapine 3.0 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening. |
|
| Esmirtazapine 4.5 mg | Experimental | Participants took placebo tablets on Days -7 and -6, esmirtazapine 4.5 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening. |
|
| Placebo | Placebo Comparator | Participants took placebo tablets on Days -7 and -6, placebo tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmirtazapine | Drug | Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name corn starch), magnesium stearate, and lactose monohydrate. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period | WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36. | From Day 1 to Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Latency to Persistent Sleep (LPS) During the In-Treatment Period | LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36. | From Day 1 to Day 36 |
| Average Subjective Total Sleep Time (TST) During the In-Treatment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26047892 | Result | Ivgy-May N, Ruwe F, Krystal A, Roth T. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a randomized, 6-week sleep laboratory trial. Sleep Med. 2015 Jul;16(7):838-44. doi: 10.1016/j.sleep.2015.04.001. Epub 2015 Apr 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Esmirtazapine 3.0 mg | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. |
| FG001 | Esmirtazapine 4.5 mg | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. |
| FG002 | Placebo | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| In-treatment Period |
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| Follow-up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Esmirtazapine 3.0 mg | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period | WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36. | The Intent-to-Treat (ITT) group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses. | Posted | Mean | Standard Deviation | Minutes | From Day 1 to Day 36 |
|
Day 1 to Day 50
Adverse events (AEs) were monitored for All Participants Treated (receiving at least one dose of study drug) during the 6-week In-treatment Period and the subsequent 1-week Follow-up Period. Six participants did not receive study drug and were not included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esmirtazapine 3.0 mg In-treatment | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development Group Leader | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
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| Placebo | Drug | The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate. |
|
TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis. |
| From Day 1 to Day 36 |
| Lack of compliance |
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| Reasons not related to trial |
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| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Randomized but not treated |
|
|
| NOT COMPLETED |
|
| Esmirtazapine 4.5 mg |
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. |
| BG002 | Placebo | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Esmirtazapine 4.5 mg | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. |
| OG002 | Placebo | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. |
|
|
| Secondary | Average Latency to Persistent Sleep (LPS) During the In-Treatment Period | LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36. | The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses. | Posted | Mean | Standard Deviation | Minutes | From Day 1 to Day 36 |
|
|
|
| Secondary | Average Subjective Total Sleep Time (TST) During the In-Treatment Period | TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis. | The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses. | Posted | Mean | Standard Deviation | Minutes | From Day 1 to Day 36 |
|
|
|
| 0 |
| 139 |
| 20 |
| 139 |
| EG001 | Esmirtazapine 4.5 mg In-treatment | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening. | 1 | 138 | 24 | 138 |
| EG002 | Placebo In-treatment | Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening. | 0 | 136 | 13 | 136 |
| EG003 | Esmirtazapine 3.0 mg Follow-up | After participants received placebo tablets during the Placebo Washout Period and 3.0 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period. | 0 | 139 | 2 | 139 |
| EG004 | Esmirtazapine 4.5 mg Follow-up | After participants received placebo tablets during the Placebo Washout Period and 4.5 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period. | 0 | 138 | 1 | 138 |
| EG005 | Placebo Follow-up | After participants received placebo tablets during the Placebo Washout Period and placebo during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period. | 0 | 136 | 1 | 136 |
| Pneumonia streptococcal | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
All publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to the Sponsor, at least 6 weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
| D013568 |
| Pathological Conditions, Signs and Symptoms |