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A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With ORG 50081 (176002)(COMPLETED)(P05707)

This study has been completed.
Sponsor:
Collaborator:
Parexcel
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00506389
First received: July 23, 2007
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this trial is to investigate the efficacy, safety and tolerability of Org 50081 compared to placebo in patients with chronic Primary Insomnia


Condition Intervention Phase
Insomnia
Quality of Life
 Drug: ORG 50081
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:

Primary Outcome Measures:
  • The Primary efficacy variable is Wake Time After Sleep Onset (WASO), averaged over all in-treatment time points and measured by polysomnography and patient diaries [ Time Frame: Prospective, six weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Latency to persistent sleep (LPS) [ Time Frame: prospective six weeks ] [ Designated as safety issue: Yes ]
  • Total Sleep Time (TST) as recorded in patient diaries [ Time Frame: prospective six weeks ] [ Designated as safety issue: Yes ]

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: 1
ORG 50081
 Drug: ORG 50081
ORG 50081 tablet once a day
Other Name: esmirtazapine maleate
Experimental: 2
ORG 50081
 Drug: ORG 50081
ORG 50081 tablet once a day
Other Name: esmirtazapine maleate
Placebo Comparator: 3
Placebo
 Drug: placebo
placebo tablet once a day

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.

Prevalence of any psychiatric disorder is two or three times higher in patients with sleep disorders. Complaints of insomnia may be early markers for psychiatric disorders such as depression, anxiety and alcohol abuse, which are associated with an increased risk of suicidality. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions.

This clinical trial is designed to assess the efficacy and safety of Org 50081 in double-blind, placebo-controlled, parallel, randomized trials with prolonged treatment periods 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:

  • between 18 and 65 years of age
  • Have a documented diagnosis of chronic primary insomnia

Exclusion Criteria:

  • Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
  • Significant medical or psychiatric illness causing the sleep disorder
  • diagnosed with major depressive disorder
  • recent substance abuse (within the year)
  • night workers or work on rotating shifts
  • serious head injury, stroke, epilepsy
  • history of bipolar disorder or family (immediate family) history of suicide
  • abnormal ECG readings at screening
  • abnormal lab values such a hematology and biochemistry
  • smoke more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
  • drink beverages containing more than 500 mg caffeine per day
  • have a positive drug test at screening for amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methadone and opiates.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00506389     History of Changes
Other Study ID Numbers: 176002, P05707
Study First Received: July 23, 2007
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Merck:
Phase three
Double-blind
placebo-controlled
parallel group
 efficacy
safety
sleep lab

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013