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

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00506389
First received: July 23, 2007
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Insomnia
Drug: Esmirtazapine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period [ Time Frame: From Day 1 to Day 36 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Average Latency to Persistent Sleep (LPS) During the In-Treatment Period [ Time Frame: From Day 1 to Day 36 ] [ Designated as safety issue: No ]
    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.

  • Average Subjective Total Sleep Time (TST) During the In-Treatment Period [ Time Frame: From Day 1 to Day 36 ] [ Designated as safety issue: No ]
    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.


Enrollment: 419
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: ORG 50081
Experimental: 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.
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.
Other Name: ORG 50081
Placebo Comparator: 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.
Drug: Placebo
The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00506389     History of Changes
Other Study ID Numbers: P05707, 176002
Study First Received: July 23, 2007
Results First Received: July 14, 2014
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Merck Sharp & Dohme Corp.:
Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014