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A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

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ClinicalTrials.gov Identifier: NCT00506389
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : August 6, 2014
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Drug: Esmirtazapine Drug: Placebo Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Six-Week Double-Blind Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab Trial With Org 50081 in Patients With Chronic Primary Insomnia
Actual Study Start Date : June 6, 2007
Actual Primary Completion Date : February 13, 2008
Actual Study Completion Date : February 13, 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Mirtazapine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Esmirtazapine 3.0 mg
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.
 Drug: Esmirtazapine
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.
Other Name: ORG 50081
Experimental: Esmirtazapine 4.5 mg
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.
 Drug: Esmirtazapine
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.
Other Name: ORG 50081
Placebo Comparator: Placebo
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.
 Drug: Placebo
The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.


Outcome Measures
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Primary Outcome Measures :
  1. Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period [ Time Frame: From Day 1 to Day 36 ]
    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.


Secondary Outcome Measures :
  1. Average Latency to Persistent Sleep (LPS) During the In-Treatment Period [ Time Frame: From Day 1 to Day 36 ]
    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.

  2. Average Subjective Total Sleep Time (TST) During the In-Treatment Period [ Time Frame: From Day 1 to Day 36 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of chronic primary insomnia

Exclusion Criteria:

  • Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
  • Has significant medical or psychiatric illness as causing the sleep disorder
  • Diagnosed with major depressive disorder
  • Substance abuse within the past year
  • Night worker or work on rotating shifts
  • Has had serious head injury, stroke, epilepsy
  • Has a history of bipolar disorder or family (immediate family) history of suicide
  • Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
  • Drinks beverages containing more than 500 mg caffeine per day
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00506389    
Other Study ID Numbers: P05707
176002 ( Other Identifier: Organon )
First Posted: July 25, 2007    Key Record Dates
Results First Posted: August 6, 2014
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Keywords provided by Merck Sharp & Dohme Corp.:
Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Mirtazapine
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Serotonin 5-HT3 Receptor Antagonists