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Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706) (RUBY)

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ClinicalTrials.gov Identifier: NCT00482612
Recruitment Status : Completed
First Posted : June 5, 2007
Results First Posted : July 10, 2014
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):

June 1, 2007
June 5, 2007
June 9, 2014
July 10, 2014
June 4, 2015
December 2006
August 2008   (Final data collection date for primary outcome measure)
Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period [ Time Frame: Day 1 to Day 15 ]
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.
Primary efficacy endpoint is is a two-week average of Total Sleep Time (TST)as recorded daily in the sleep diary [ Time Frame: Two Weeks ]
Complete list of historical versions of study NCT00482612 on ClinicalTrials.gov Archive Site
  • Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period [ Time Frame: Day 1 to Day 15 ]
    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.
  • Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period [ Time Frame: Day 1 to Day 15 ]
    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.
  • Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period [ Time Frame: Day 1 to Day 15 ]
    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.
To investigate the safety and tolerability of Org 50081 [ Time Frame: Two Weeks ]
Not Provided
Not Provided
 
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
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
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Insomnia
  • Drug: Esmirtazapine
    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.
    Other Names:
    • Org 50081
    • MK-8265
  • Drug: Placebo
    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.
  • Experimental: Esmirtazapine 1.5 mg
    Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
    Intervention: Drug: Esmirtazapine
  • Experimental: Esmirtazapine 3.0 mg
    Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks
    Intervention: Drug: Esmirtazapine
  • Experimental: Esmirtazapine 4.5 mg
    Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
    Intervention: Drug: Esmirtazapine
  • Placebo Comparator: Placebo
    Placebo to esmirtazapine
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
526
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has signed written informed consent after the scope and nature of the investigation was explained to them
  • Has difficulty falling asleep, maintaining sleep or has early morning awakenings

Exclusion Criteria:

  • Significant medical or psychiatric illness causing sleep disturbances
  • Has a history of bipolar disorder or family (immediate family) of suicide
  • Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy
  • Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year
  • Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years
  • Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   United States
 
NCT00482612
P05706
176001 ( Other Identifier: Protocol number )
MK-8265-003 ( Other Identifier: Protocol number )
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP