Safety and Efficacy of Ramelteon in Healthy Subjects
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Phase-Shifting Effects of Repeated Daily Dosing of Ramelteon in Healthy Subjects
2 other identifiers
interventional
75
1 country
13
Brief Summary
The purpose of this study is to determine the phase-advance in circadian rhythms in healthy adults subjects taking ramelteon, once daily (QD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2005
Shorter than P25 for phase_2
13 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
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
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
2 months
May 1, 2008
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dim Light Melatonin Secretion Offset Time.
Days 1, 2, 3, and 4 or Final Visit.
Secondary Outcomes (1)
Dim-Light Melatonin Onset (DLMOn) time.
Days 1, 2, 3, and 4 or Final Visit.
Study Arms (5)
Ramelteon 1 mg QD
EXPERIMENTALRamelteon 2 mg QD
EXPERIMENTALRamelteon 4 mg QD
EXPERIMENTALRamelteon 8 mg QD
EXPERIMENTALPlacebo QD
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
- Habitual bedtime is between 10:00 p.m. and 1:00 a.m.
- Body mass index between 18 and 30, inclusive.
- Medial subjective sleep latency of less than 30 minutes and a median subjective total sleep time of greater than 6.5 but less than 9 hours.
You may not qualify if:
- Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
- 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 the first dose of single-blind study medication, whichever is longer.
- Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
- Flown across greater than three time zones within 21 days prior to or during screening.
- Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication.
- Ever had a history of seizures, sleep apnea, restless leg syndrome, periodic limb movement syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
- History of primary sleep disorders as determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised within the past 6 months.
- History of psychiatric disorder (including anxiety or depression) within the past 12 months.
- 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, or consumes any alcoholic drinks 2 hours prior to bedtime.
- History of drug abuse within the past 12 months.
- Current neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease.
- Apnea hypopnea index (per hour of sleep) greater than 10.
- Periodic leg movement syndrome with arousal index (per hour of sleep) greater than 10 as seen on the polysomnography screening night.
- Positive urine drug screen.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (13)
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Danville, Indiana, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Metairie, Louisiana, United States
Unknown Facility
Chevy Chase, Maryland, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Dublin, Ohio, United States
Unknown Facility
Columbia, South Carolina, United States
Related Publications (1)
Richardson GS, Zee PC, Wang-Weigand S, Rodriguez L, Peng X. Circadian phase-shifting effects of repeated ramelteon administration in healthy adults. J Clin Sleep Med. 2008 Oct 15;4(5):456-61.
PMID: 18853704RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP Clinical Science
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
March 1, 2005
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
February 28, 2012
Record last verified: 2012-02