{"protocolSection":{"identificationModule":{"nctId":"NCT00482612","orgStudyIdInfo":{"id":"P05706"},"secondaryIdInfos":[{"id":"176001","type":"OTHER","domain":"Protocol number"},{"id":"MK-8265-003","type":"OTHER","domain":"Protocol number"}],"organization":{"fullName":"Merck Sharp & Dohme LLC","class":"INDUSTRY"},"briefTitle":"Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)","officialTitle":"A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia","acronym":"RUBY"},"statusModule":{"statusVerifiedDate":"2018-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-12-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2008-08-11","type":"ACTUAL"},"completionDateStruct":{"date":"2008-08-11","type":"ACTUAL"},"studyFirstSubmitDate":"2007-06-01","studyFirstSubmitQcDate":"2007-06-04","studyFirstPostDateStruct":{"date":"2007-06-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-06-09","resultsFirstSubmitQcDate":"2014-06-09","resultsFirstPostDateStruct":{"date":"2014-07-10","type":"ESTIMATED"},"dispFirstSubmitDate":"2009-04-29","dispFirstSubmitQcDate":"2009-10-02","dispFirstPostDateStruct":{"date":"2009-10-06","type":"ESTIMATED"},"lastUpdateSubmitDate":"2018-09-04","lastUpdatePostDateStruct":{"date":"2018-10-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Merck Sharp & Dohme LLC","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"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."},"conditionsModule":{"conditions":["Insomnia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":526,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Esmirtazapine 1.5 mg","type":"EXPERIMENTAL","description":"Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks","interventionNames":["Drug: Esmirtazapine"]},{"label":"Esmirtazapine 3.0 mg","type":"EXPERIMENTAL","description":"Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks","interventionNames":["Drug: Esmirtazapine"]},{"label":"Esmirtazapine 4.5 mg","type":"EXPERIMENTAL","description":"Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks","interventionNames":["Drug: Esmirtazapine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo to esmirtazapine","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Esmirtazapine","description":"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.","armGroupLabels":["Esmirtazapine 1.5 mg","Esmirtazapine 3.0 mg","Esmirtazapine 4.5 mg"],"otherNames":["Org 50081","MK-8265"]},{"type":"DRUG","name":"Placebo","description":"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.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period","description":"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.","timeFrame":"Day 1 to Day 15"}],"secondaryOutcomes":[{"measure":"Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period","description":"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.","timeFrame":"Day 1 to Day 15"},{"measure":"Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period","description":"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.","timeFrame":"Day 1 to Day 15"},{"measure":"Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period","description":"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.","timeFrame":"Day 1 to Day 15"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Has signed written informed consent after the scope and nature of the investigation was explained to them\n* Has difficulty falling asleep, maintaining sleep or has early morning awakenings\n\nExclusion Criteria:\n\n* Significant medical or psychiatric illness causing sleep disturbances\n* Has a history of bipolar disorder or family (immediate family) of suicide\n* Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy\n* Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year\n* Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years\n* Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Medical Director","affiliation":"Merck Sharp & Dohme LLC","role":"STUDY_DIRECTOR"}]},"referencesModule":{"references":[{"pmid":"26047890","type":"RESULT","citation":"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."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf","url":"http://engagezone.msd.com/ds_documentation.php"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Esmirtazapine 1.5 mg","description":"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."},{"id":"FG001","title":"Esmirtazapine 3.0 mg","description":"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."},{"id":"FG002","title":"Esmirtazapine 4.5 mg","description":"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."},{"id":"FG003","title":"Placebo","description":"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."}],"periods":[{"title":"In-treatment Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"137"},{"groupId":"FG001","numSubjects":"125"},{"groupId":"FG002","numSubjects":"129"},{"groupId":"FG003","numSubjects":"135"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"137"},{"groupId":"FG001","numSubjects":"125"},{"groupId":"FG002","numSubjects":"128"},{"groupId":"FG003","numSubjects":"135"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"137"},{"groupId":"FG001","numSubjects":"125"},{"groupId":"FG002","numSubjects":"128"},{"groupId":"FG003","numSubjects":"135"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}],"dropWithdraws":[{"type":"No study medication administered","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Follow-up Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"137"},{"groupId":"FG001","numSubjects":"125"},{"groupId":"FG002","numSubjects":"128"},{"groupId":"FG003","numSubjects":"135"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"123"},{"groupId":"FG001","numSubjects":"107"},{"groupId":"FG002","numSubjects":"106"},{"groupId":"FG003","numSubjects":"127"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"8"}]}],"dropWithdraws":[{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Lack of compliance","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Reasons not related to trial","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"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.","groups":[{"id":"BG000","title":"Esmirtazapine 1.5 mg","description":"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."},{"id":"BG001","title":"Esmirtazapine 3.0 mg","description":"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."},{"id":"BG002","title":"Esmirtazapine 4.5 mg","description":"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."},{"id":"BG003","title":"Placebo","description":"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."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"137"},{"groupId":"BG001","value":"125"},{"groupId":"BG002","value":"128"},{"groupId":"BG003","value":"135"},{"groupId":"BG004","value":"525"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.8","spread":"12.4"},{"groupId":"BG001","value":"45.6","spread":"12.0"},{"groupId":"BG002","value":"44.5","spread":"12.2"},{"groupId":"BG003","value":"46.2","spread":"11.3"},{"groupId":"BG004","value":"45.3","spread":"12.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"72"},{"groupId":"BG003","value":"90"},{"groupId":"BG004","value":"339"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"56"},{"groupId":"BG003","value":"45"},{"groupId":"BG004","value":"186"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period","description":"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.","populationDescription":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Minutes","timeFrame":"Day 1 to Day 15","groups":[{"id":"OG000","title":"Esmirtazapine 1.5 mg","description":"Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG001","title":"Esmirtazapine 3.0 mg","description":"Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG002","title":"Esmirtazapine 4.5 mg","description":"Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG003","title":"Placebo","description":"Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"126"},{"groupId":"OG003","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"382.14","spread":"68.155"},{"groupId":"OG001","value":"382.77","spread":"81.172"},{"groupId":"OG002","value":"394.83","spread":"85.575"},{"groupId":"OG003","value":"351.40","spread":"78.551"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Baseline TST was used as a covariate."},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Baseline TST was used as a covariate."},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Baseline TST was used as a covariate."}]},{"type":"SECONDARY","title":"Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period","description":"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.","populationDescription":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Minutes","timeFrame":"Day 1 to Day 15","groups":[{"id":"OG000","title":"Esmirtazapine 1.5 mg","description":"Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG001","title":"Esmirtazapine 3.0 mg","description":"Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG002","title":"Esmirtazapine 4.5 mg","description":"Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG003","title":"Placebo","description":"Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"126"},{"groupId":"OG003","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"48.93","spread":"34.59"},{"groupId":"OG001","value":"52.02","spread":"38.95"},{"groupId":"OG002","value":"50.80","spread":"45.76"},{"groupId":"OG003","value":"60.13","spread":"42.98"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0014","statisticalMethod":"ANCOVA","statisticalComment":"Baseline SL was used as a covariate."},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0135","statisticalMethod":"ANCOVA","statisticalComment":"Baseline SL was used as a covariate."},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","statisticalComment":"Baseline SL was used as a covariate."}]},{"type":"SECONDARY","title":"Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period","description":"The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. 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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.","populationDescription":"The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Number of participants","timeFrame":"Day 1 to Day 15","groups":[{"id":"OG000","title":"Esmirtazapine 1.5 mg","description":"Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG001","title":"Esmirtazapine 3.0 mg","description":"Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG002","title":"Esmirtazapine 4.5 mg","description":"Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period."},{"id":"OG003","title":"Placebo","description":"Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"125"},{"groupId":"OG002","value":"128"},{"groupId":"OG003","value":"135"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"28"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period","description":"The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. 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