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

NCT ID: NCT00482612

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 526 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-07
• Study Completion Date: 2008-08-11

Brief 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.

Conditions

Insomnia

Study Design

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

Study Groups

Esmirtazapine 1.5 mg

Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks

Group Type: EXPERIMENTAL

Esmirtazapine

Intervention Type: DRUG

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.

Esmirtazapine 3.0 mg

Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks

Group Type: EXPERIMENTAL

Esmirtazapine

Intervention Type: DRUG

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.

Esmirtazapine 4.5 mg

Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks

Group Type: EXPERIMENTAL

Esmirtazapine

Intervention Type: DRUG

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 to esmirtazapine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Org 50081; MK-8265

Eligibility Criteria

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.

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 26047890 (View on PubMed)

Other Identifiers

176001

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8265-003

Identifier Type: OTHER

Identifier Source: secondary_id

P05706

Identifier Type: -

Identifier Source: org_study_id