Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: Transient Insomnia

In brief

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

Key facts

Study ID

NCT00671398

Run by

Takeda

People needed

289

Starts

2002-12-01

Expected to finish

2003-05-01

Last updated by the study team

2012-02-28

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Palm Springs, California, United States
• Study site — San Diego, California, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Overland Park, Kansas, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dublin, Ohio, United States
• Study site — Columbia, South Carolina, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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