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

NCT00482612 | Completed Phase 3 Results

• 3 other identifiers: P05706176001MK-8265-003
• Study Type: interventional
• Target: 526
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period

  Day 1 to Day 15

• Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period

  Day 1 to Day 15

• Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period

  Day 1 to Day 15

Study Arms (4)

Esmirtazapine 1.5 mg

EXPERIMENTAL

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

Drug: Esmirtazapine

Esmirtazapine 3.0 mg

EXPERIMENTAL

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

Drug: Esmirtazapine

Esmirtazapine 4.5 mg

EXPERIMENTAL

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

Drug: Esmirtazapine

Placebo

PLACEBO COMPARATOR

Placebo to esmirtazapine

Drug: Placebo

Interventions

Esmirtazapine 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.

Also known as: Org 50081, MK-8265

Esmirtazapine 1.5 mg; Esmirtazapine 3.0 mg; Esmirtazapine 4.5 mg

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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.

  PMID: 26047890 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 5, 2007
• Study Start: December 7, 2006
• Primary Completion: August 11, 2008
• Study Completion: August 11, 2008
• Last Updated: October 3, 2018
• Results First Posted: July 10, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share