Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

NCT00492011 | Completed Phase 4

• 2 other identifiers: 01-04-TL-375-045U1111-1115-1566
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Circadian Dysregulation

Keywords

Circadian Rhythm Disorders; Biological Clock Disturbances; Jet Lag Syndrome; Time Zone Change Syndrome; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Average Latency to Persistent Sleep measured by polysomnography.

  Nights 2, 3, and 4

Secondary Outcomes (11)

• Dim light melatonin offset time in a subset of subjects defined as the time of the morning when the melatonin drops to below 3 pg/mL with a downward slope.

  Nights 2, 3, and 4

• Total sleep time in minutes by polysomnography.

  Nights 2, 3, and 4

• Number of awakenings after persistent sleep by polysomnography.

  Nights 2, 3, and 4

• Wake time after persistent sleep onset by polysomnography.

  Nights 2, 3, and 4

• Sleep efficiency by polysomnography.

  Nights 2, 3, and 4

Study Arms (4)

Ramelteon 1 mg QD

EXPERIMENTAL

Drug: Ramelteon

Ramelteon 4 mg QD

EXPERIMENTAL

Drug: Ramelteon

Ramelteon 8 mg QD

EXPERIMENTAL

Drug: Ramelteon

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 1 mg, tablets, orally, once nightly for 4 nights.

Also known as: TAK-375, Rozerem™

Ramelteon 1 mg QD

Placebo DRUG

Ramelteon placebo-matching tablets, orally, once nightly for 4 nights.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

Honolulu, Hawaii, United States

Location

Unknown Facility

New York, New York, United States

Location

Related Publications (1)

• Zee PC, Wang-Weigand S, Wright KP Jr, Peng X, Roth T. Effects of ramelteon on insomnia symptoms induced by rapid, eastward travel. Sleep Med. 2010 Jun;11(6):525-33. doi: 10.1016/j.sleep.2010.03.010. Epub 2010 May 18.

  PMID: 20483660 RESULT

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Chronobiology Disorders; Jet Lag Syndrome

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Circadian Rhythm; Dyssomnias; Sleep Wake Disorders; Travel-Related Illness; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: February 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (4)