Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414102
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : June 28, 2016
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Brief Summary:
The purpose of this study is to determine the subjective treatment effects of ramelteon, once daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Drug: Ramelteon Drug: Placebo Phase 4

Detailed Description:

Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.

Ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep onset under the brand name of Rozerem™.

This study will be comprised of two groups of subjects, 1) an outpatient group and 2) an inpatient group. The inpatient group will be used as reference arm as previously conducted studies in the sleep laboratory setting. Study participation is anticipated to be about 50 days (approximately 1.75 months).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 552 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Demonstrate the Subjective Treatment Effects of Ramelteon on Sleep Using a Post Sleep Questionnaire - Interactive Voice Response System (PSQ-IVRS) in an "At-Home Setting" in an Adult Population With Chronic Insomnia
Study Start Date : October 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon

Arm Intervention/treatment
Experimental: Ramelteon 8 mg QD Drug: Ramelteon
Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.
Other Names:
  • TAK-375
  • Rozerem™

Placebo Comparator: Placebo QD Drug: Placebo
Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.

Primary Outcome Measures :
  1. Average subjective Sleep Latency from Day 15 to Day 21 [ Time Frame: Day 22 ]

Secondary Outcome Measures :
  1. Subjective Measures of Sleep Latency. [ Time Frame: Weeks 1 and 2 or Final Visit ]
  2. Subjective Total Sleep Time. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ]
  3. Wake Time after Sleep Onset [ Time Frame: Weeks 1, 2 and 3 or Final Visit ]
  4. Number of Awakenings. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ]
  5. Quality of Sleep. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ]
  6. Rebound insomnia assessed from Nights 22 to 28 via self-reported sleep latency. [ Time Frame: Day 29 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Body mass index between 18 and 34, inclusive.
  • Based on sleep history, has had chronic insomnia for at least 3 months.
  • Based on sleep history, reports a history of subjective sleep latency greater than or equal to 60 min and a subjective total sleep time of less than or equal to 6.5 hours.
  • The difference of the average subjective sleep latency from days 1-3 to days 5-7 has to be less than or equal to 20 minutes during the single blind run-in period.
  • On at least 3 of the first 5 nights of single-blind run-in placebo treatment, the subject must have an subjective sleep latency of greater than or equal to 45 minutes and subjective total sleep time of less than or equal to 6.5 hours.
  • Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.
  • Willing to have a fixed bedtime and agrees to go to bed within 30 minutes of the habitual bedtime during the entire study.
  • Consistent access to a touch-tone phone and are willing to complete all paper and telephone questionnaires within 60 minutes of awakening each morning throughout the entire duration of the study.
  • Willing to remain in bed for at least 6.5 hours each night during the entire study.
  • Based on sleep history, uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.

Exclusion Criteria

  • Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
  • Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
  • Has sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
  • Has flown across greater than 3 time zones within 7 days prior to screening, or will travel across 2 or more time zones during the course of the study.
  • Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
  • Has ever had a history of seizures; sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease, fibromyalgia, or a positive test result for the aforementioned ailments on the screening polysomnography.
  • History of psychiatric disorder within the past 6 months.
  • History of drug addiction or drug abuse within the past 12 months.
  • History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or for the inpatient subject consumed any alcoholic drinks within 24 hours of any polysomnography visits.
  • Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
  • Uses tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle.
  • Positive urine drug screen at initial screening Visit 2.
  • For inpatient subjects: has a positive breathalyzer test on any of the PSG assessment visits.
  • Exhibit a placebo response during single blinded placebo run in period.
  • Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
  • Any additional condition(s) that in the Investigator's opinion would:

    • affect sleep/wake function
    • prohibit the subject from completing the study
    • indicate that continuation in the study would not be in the best interests of the subject.
  • Positive hepatitis panel including hepatitis A virus- Immunoglobulin M, hepatitis-B surface antigen, hepatitis C virus antibody.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including the following:

    • Anxiolytics Antipsychotics
    • over-the-counter and Prescription Sedatives
    • Hypnotics
    • Narcotic analgesics
    • Antidepressants
    • Beta-blockers
    • Anticonvulsants
    • St. John's wort
    • Sedating H1 antihistamines
    • Kava-kava
    • Systemic steroids
    • Ginkgo-biloba
    • Respiratory stimulants
    • over-the-counter and prescription diet aids
    • Sedating Decongestants
    • Muscle relaxants
    • Melatonin and all other drugs or supplements known to affect sleep/wake function.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00414102

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Sponsors and Collaborators
Study Director: Medical Director Clinical Science Takeda Global Research & Development Center

Additional Information:
Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc. Identifier: NCT00414102     History of Changes
Other Study ID Numbers: 01-05-TL-375-069
U1111-1115-2043 ( Registry Identifier: WHO )
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: May 2010

Keywords provided by Takeda:
Chronic Insomnia
Sleep Initiation and Maintenance Disorder
Drug Therapy

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