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

Insomnia Clinical Trial

— RUBY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482612
• Other study ID #: P05706
• Secondary ID: 176001MK-8265-00
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2006
• Est. completion date: August 11, 2008

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: August 11, 2008
• Est. primary completion date: August 11, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1 to Day 15
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.	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.	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.	Day 1 to Day 15