Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 176001 | Other Identifier | Protocol number | |
| MK-8265-003 | Other Identifier | Protocol number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esmirtazapine 1.5 mg | Experimental | Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks |
|
| Esmirtazapine 3.0 mg | Experimental | Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks |
|
| Esmirtazapine 4.5 mg | Experimental | Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks |
|
| Placebo | Placebo Comparator | Placebo to esmirtazapine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmirtazapine | Drug | Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, 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. Tablets were administered orally once daily about 30 minutes prior to bedtime. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period | TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active 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 present was used in the analysis. | Day 1 to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period | SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26047890 | Result | Ivgy-May N, Roth T, Ruwe F, Walsh J. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a 2-week randomized outpatient trial. Sleep Med. 2015 Jul;16(7):831-7. doi: 10.1016/j.sleep.2015.03.005. Epub 2015 Mar 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Esmirtazapine 1.5 mg | Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered. |
| FG001 | Esmirtazapine 3.0 mg | Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered. |
| FG002 | Esmirtazapine 4.5 mg | Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered. |
| FG003 | Placebo | Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| In-treatment Period |
|
| |||||||||||||||||||||
| Follow-up Period |
|
Baseline characteristics were reported for the All-Subjects-Treated group. One participant who was randomized to receive MK-8265 4.5 mg did not receive double-blind study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Esmirtazapine 1.5 mg | Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period. |
| BG001 | Esmirtazapine 3.0 mg |
| 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 Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period | TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active 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 present was used in the analysis. | The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication, and had baseline and at least one post-baseline measurement for at least one efficacy assessment. | Posted | Mean | Standard Deviation | Minutes | Day 1 to Day 15 |
|
From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esmirtazapine 1.5 mg In-treatment | Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA v.11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA v.11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Drug | Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime. |
|
| Day 1 to Day 15 |
| Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period | The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Day 1 to Day 15 |
| Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period | The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Day 1 to Day 15 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
| BG002 | Esmirtazapine 4.5 mg | Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period. |
| BG003 | Placebo | Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Esmirtazapine 3.0 mg | Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. |
| OG002 | Esmirtazapine 4.5 mg | Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. |
| OG003 | Placebo | Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. |
|
|
|
| Secondary | Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period | SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis. | The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication and had baseline and at least one post-baseline measurement for at least one efficacy assessment. | Posted | Mean | Standard Deviation | Minutes | Day 1 to Day 15 |
|
|
|
|
| Secondary | Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period | The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication. | Posted | Number | Number of participants | Day 1 to Day 15 |
|
|
|
| Secondary | Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period | The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication. | Posted | Number | Number of participants | Day 1 to Day 15 |
|
|
|
| 2 |
| 137 |
| 10 |
| 137 |
| EG001 | Esmirtazapine 3.0 mg In-Treatment | Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. | 1 | 125 | 11 | 125 |
| EG002 | Esmirtazapine 4.5 mg In-treatment | Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. | 1 | 128 | 9 | 128 |
| EG003 | Placebo In-treatment | Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. | 0 | 135 | 2 | 135 |
| EG004 | Esmirtazapine 1.5 mg Follow-up | After receiving 1.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered. | 0 | 137 | 0 | 137 |
| EG005 | Esmirtazapine 3.0 mg Folow-up | After receiving 3.0 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered. | 0 | 125 | 0 | 125 |
| EG006 | Esmirtazapine 4.5 mg Follow-up | After receiving 4.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered. | 0 | 128 | 0 | 128 |
| EG007 | Placebo Follow-up | After receiving placebo in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered. | 0 | 135 | 0 | 135 |
| Bronchitis | Infections and infestations | MedDRA v.11.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA v.11.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v.11.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v.11.0 | Systematic Assessment |
|
| Abdominoplasty | Surgical and medical procedures | MedDRA v.11.0 | 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.
| D001523 |
| Mental Disorders |
| 0.0135 |
| Superiority or Other |
| ANCOVA | Baseline SL was used as a covariate. | <0.0001 | Superiority or Other |