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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482612
First received: June 1, 2007
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine if esmirtazapine maleate is a safe and effective treatment for insomnia.


Condition Intervention Phase
Insomnia
Drug: Esmirtazapine maleate 1.5 mg
Drug: Esmirtazapine maleate 3.0 mg
Drug: Esmirtazapine maleate 4.5 mg
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 Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia

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

Primary Outcome Measures:
  • Double-blind period average for the Total Sleep Time (TST) as recorded daily in the sleep diary [ Time Frame: Two Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of Org 50081 [ Time Frame: Two Weeks ] [ Designated as safety issue: No ]

Enrollment: 526
Study Start Date: December 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esmirtazapine maleate 1.5 mg
Esmirtazapine maleate, 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
Drug: Esmirtazapine maleate 1.5 mg
Esmirtazapine maleate was provided as tablets for oral use containing 1.5 mg of active compound (i.e., Org 4420). In addition, tablets contain 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.
Other Names:
  • Org 50081
  • MK-8265
Experimental: Esmirtazapine maleate 3.0 mg
Esmirtazapine maleate, 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks
Drug: Esmirtazapine maleate 3.0 mg
Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg of active compound (i.e., Org 4420). In addition, tablets contain 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.
Other Names:
  • ORG 50081
  • MK-8265
Experimental: Esmirtazapine maleate 4.5 mg
Esmirtazapine maleate, 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
Drug: Esmirtazapine maleate 4.5 mg
Esmirtazapine maleate was provided as tablets for oral use containing 4.5 mg of active compound (i.e., Org 4420). In addition, tablets contain 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.
Other Names:
  • Org 50081
  • MK-8265
Placebo Comparator: Placebo
Placebo to esmirtazapine maleate
Drug: Placebo
Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate. For oral administration once daily ~30 min prior to bedtime.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are at least 18 and less than 65 years of age;
  • Sign written informed consent after the scope and nature of the investigation have been explained to them.
  • Have difficulty falling asleep; maintaining sleep or early morning awakenings.

Exclusion Criteria:

  • Significant medical or psychiatric illness causing sleep disturbances
  • Have a history of bipolar disorder or family (immediate family) of suicide
  • Sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy.
  • Significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year.
  • Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482612     History of Changes
Other Study ID Numbers: P05706, 176001, MK-8265-003
Study First Received: June 1, 2007
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014