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Status:

COMPLETED

Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

Lead Sponsor:

Takeda

Conditions:

Transient Insomnia

Eligibility:

All Genders

18-64 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.

Detailed Description

Insomnia is characterized by difficulties initiating and maintaining sleep, or of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US pop...

Eligibility Criteria

Inclusion

  • 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.
  • Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
  • Sleeps 6.5 to 8 hours per night and has a subjective sleep latency of less than or equal to 30 minutes.
  • Body mass index between 18 and 34, inclusive.
  • Exclusion Criteria:
  • Any history of insomnia.
  • Spent one or more nights in a sleep laboratory.
  • Epworth Sleepiness Scale score of greater than 10.
  • Known hypersensitivity to Ramelteon or related compounds, including melatonin.
  • Previously participated in a study involving Ramelteon.
  • Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.
  • Sleep schedule changes required by employment (ie, shift work) within three months preceding Day 1 or has flown across greater than three time zones within seven days prior to screening.
  • Participated in a weight loss program or substantially altered their exercise routine within 30 days prior to Day 1.
  • History of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
  • History of a psychiatric disorder (including anxiety or depression) within the past 12 months.
  • History of drug addiction or drug abuse within the past 12 months.
  • Any physical or psychiatric disorder that may be associated with sleep disturbance.
  • History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
  • Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic or metabolic disease.
  • Uses tobacco products during nightly awakenings.
  • Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
  • Positive hepatitis panel.
  • Positive urine drug screen including alcohol at screening or a positive breathalyzer test at check-in.
  • Any additional condition(s) that in the investigator's opinion would
  • affect sleep-wake function
  • prohibit the subject from completing the study
  • not be in the best interest of the subject.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
  • Anxiolytics
  • Hypnotics
  • Antidepressants
  • Anticonvulsants
  • Sedating H1 antihistamines
  • Systemic steroids
  • Respiratory stimulants (eg, theophylline)
  • Decongestants
  • Over-the-counter and prescription stimulants
  • Over-the-counter and prescription diet aids
  • Central nervous system active drugs
  • Narcotic analgesics
  • All beta blockers
  • St. John's Wort
  • Kava-kava
  • gingko biloba

Exclusion

    Key Trial Info

    Start Date :

    December 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2003

    Estimated Enrollment :

    289 Patients enrolled

    Trial Details

    Trial ID

    NCT00671398

    Start Date

    December 1 2002

    End Date

    May 1 2003

    Last Update

    February 28 2012

    Active Locations (12)

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    Page 1 of 3 (12 locations)

    1

    Palm Springs, California, United States

    2

    San Diego, California, United States

    3

    Miami, Florida, United States

    4

    Pembroke Pines, Florida, United States