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

NCT ID: NCT00506389

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 419 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-06
• Study Completion Date: 2008-02-13

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.

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Esmirtazapine

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Esmirtazapine

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

ORG 50081

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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 Apr 16.

Reference Type: RESULT

PMID: 26047892 (View on PubMed)

Other Identifiers

176002

Identifier Type: OTHER

Identifier Source: secondary_id

P05707

Identifier Type: -

Identifier Source: org_study_id