Efficacy of Ramelteon on Transient Insomnia in Healthy Adults
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia
2 other identifiers
interventional
289
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2002
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 1, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedFebruary 28, 2012
February 1, 2012
5 months
May 1, 2008
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory.
Day 1
Secondary Outcomes (15)
Total Sleep Time.
Days 1 and 2.
Sleep Efficiency.
Days 1 and 2.
Wake Time after Persistent Sleep Onset.
Days 1 and 2.
Number of Awakenings after Persistent Sleep.
Days 1 and 2.
Subjective Sleep Latency.
Day 2
- +10 more secondary outcomes
Study Arms (3)
Ramelteon 8 mg QD
EXPERIMENTALRamelteon 16 mg QD
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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.
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (12)
Unknown Facility
Palm Springs, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Dublin, Ohio, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Houston, Texas, United States
Related Publications (1)
Zammit G, Schwartz H, Roth T, Wang-Weigand S, Sainati S, Zhang J. The effects of ramelteon in a first-night model of transient insomnia. Sleep Med. 2009 Jan;10(1):55-9. doi: 10.1016/j.sleep.2008.04.010. Epub 2008 Aug 8.
PMID: 18691937RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP Clinical Science
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
May 1, 2008
First Posted
May 5, 2008
Study Start
December 1, 2002
Primary Completion
May 1, 2003
Study Completion
May 1, 2003
Last Updated
February 28, 2012
Record last verified: 2012-02