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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506389
• Other study ID #: P05707
• Secondary ID: 176002
• Status: Completed
• Phase: Phase 3
• Start date: June 6, 2007
• Est. completion date: February 13, 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 trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: February 13, 2008
• Est. primary completion date: February 13, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• Placebo
The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Parexel

References & Publications (1)

Ivgy-May N, Ruwe F, Krystal A, Roth T. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a randomized, 6-week sleep laboratory trial. Sleep Med. 2015 Jul;16(7):838-44. doi: 10.1016/j.sleep.2015.04.001. Epub 2015 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period	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.	From Day 1 to Day 36
Secondary	Average Latency to Persistent Sleep (LPS) During the In-Treatment Period	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.	From Day 1 to Day 36
Secondary	Average Subjective Total Sleep Time (TST) During the In-Treatment Period	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.	From Day 1 to Day 36