Overview
Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers
Status:
Completed
Completed
Trial end date:
2007-08-01
2007-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Takeda
Criteria
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.
- Willing to travel from Hawaii to the East Coast and have a minimum stay of 6 days at
the destination in a sleep laboratory during the entire study.
- Has lived in Hawaii for at least 12 months and has not been traveling outside of
Hawaii for 4 consecutive days within 30 days prior to the Outpatient Screening Visit.
- History of sleep disturbance associated with jet lag symptoms, with at least two
occurrences in the last three years, as defined in the International Classification of
Sleep Disorders.
- Habitual bedtime should be determined by sleep history as between 9:00 PM and 12:00 AM
as determined by sleep history prior to randomization.
- Have regular bedtime (within 1 hour) for 1 week prior to travel.
- The subject has a subjective sleep latency of less than 30 minutes and a subjective
total sleep time of 6.5 hours but less than 9 hours, as determined by sleep history.
- Mean subjective sleep latency of less than 30 minutes and a mean subjective total
sleep time of greater than 6.5 hours but less than 9 hours in 3 of 5 nights after the
outpatient screening visit, as determined by post-sleep questionnaire.
- Willingness and ability to comply with study procedures, including travel time, sleep,
and waking-hour activities, light-exposure restriction, and food intake.
- Body mass index between 18 and 34, inclusive.
- Negative test result for selected substances of abuse (including alcohol) at Initial
Screening, the In-Patient Actigraphy Screening Nights 1 and 2, and the Treatment
Period.
- Negative test result for hepatitis B Surface antigen and hepatitis C virus antibody.
Exclusion Criteria
- Known hypersensitivity to ramelteon or related compounds, including melatonin, and
melatonin related compounds.
- History of primary sleep disorders as determined by the Diagnostic and Statistical
Manual of Mental Disorders, 4th Edition Revised within the past 6 months.
- Current sleep disorder as assessed by presence of sleep apnea, period leg movement
syndrome, insomnia, daytime napping of more than 20 minutes, chronic fatigue.
- Ever had a history of seizures, sleep apnea, restless leg syndrome, periodic limb
movement syndrome, or chronic obstructive pulmonary disease.
- History of psychiatric disorder (including schizophrenia, bipolar disorder, mental
retardation, or cognitive disorder, anxiety, or depression) within the past 12 months.
- Current, clinically significant neurological (including cognitive), hepatic, renal,
endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic
disease, as determined by the investigator.
- 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.
- History of drug abuse within the past 12 months, as defined in Diagnostic and
Statistical Manual of Mental Disorders, 4th Edition Revised.
- Positive urine drug screen or a positive urine drug screen or alcohol breathalyzer
test.
- Sleep schedule changes required by employment (eg, shift worker) within 3 months prior
to the administration of single blind study medication.
- Positive hepatitis panel including anti- hepatitis A virus (only IgM is exclusionary),
hepatitis B surface antigen, or anti- hepatitis C virus.
- 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
- cause a situation such that it would not be in the best interest of the subject
to participate in the study.
- Participated in a weight loss program or has substantially altered their exercise
routine within 30 days prior to the administration of study medication.
- Smokes greater than 3 cigarettes per day or uses tobacco products during nightly
awakenings.
- Has flown across greater than 3 time zones within 28 days prior to or during
screening.
- Reports high caffeine consumption (greater than 600 mg daily).
- Participated in any other investigational study and/or taken any investigational drug
within 30 days or 5 half-lives of the investigational drug prior to the first dose of
double blind study medication, whichever is longer.
- Used any central nervous system medication within 1 week (or 5 half lives of the drug,
whichever is longer) prior to the administration of study medication. These
medications must not have been used to treat psychiatric disorders.
- Used prescription or over-the-counter (OTC) hypnotic medication (including melatonin)
within 3 months of the screening visits.
- 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:
- Anxiolytics
- Sedatives
- Antidepressants
- CNS active drugs (including herbal)
- Anticonvulsants
- Narcotic analgesics
- Sedating H1 antihistamines
- St. John's Wort
- Systemic steroids
- Kava-kava
- Respiratory stimulants
- Ginkgo-biloba
- Decongestants
- Over-the-counter and prescription stimulants
- Antipsychotics
- Over-the-counter and prescription diet aids
- Muscle Relaxants Drugs affecting sleep/wake function
- Melatonin
- Modafinil