Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia
A Phase III Safety Study to Evaluate the Long-term Effects of TAK-375 on Endocrine Function in Adult Subjects With Chronic Insomnia
2 other identifiers
interventional
122
1 country
29
Brief Summary
The purpose of this study is to determine the long-term effects of Ramelteon, once daily (QD), on endocrine function values.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2003
29 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
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedFebruary 28, 2012
February 1, 2012
1.5 years
March 12, 2008
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Total Serum Thyroxine.
Months 1, 2, 3, 4, 5, and 6 or Final Visit
Secondary Outcomes (13)
Change from baseline in free thyroxine.
Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in thyroid stimulating hormone.
Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in triiodothyronine.
Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in total testosterone (men only).
Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change from baseline in free testosterone (men only).
Months 1, 2, 3, 4, 5, and 6 or Final Visit
- +8 more secondary outcomes
Study Arms (2)
Ramelteon 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.
- Has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep.
- Has a subjective sleep latency (sSL) greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours for at least 3 nights out of one week.
- Habitual bedtime is between 8:30PM and 12:00AM.
- Habitual awakening time is between 5:00 AM and 10:00 AM.
- Male and female subjects must have serum prolactin, luteinizing hormone, follicle stimulating hormone, adrenocorticotropic hormone, thyroid stimulating hormone, triiodothyronine and thyroxine within normal range. Normal ranges for luteinizing hormone and follicle stimulating hormone for female subjects will be defined as the lowest value among the menstrual phases to the highest value among the menstrual phases.
- Body mass index between 18 and 34, inclusive.
- Male subjects must have serum testosterone values of greater than or equal to 150 ng per dL.
- Female subjects must have serum estradiol values within normal range.
You may not qualify if:
- 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 (eg, shift worker) within three months prior to Day 1, or has flown across greater than three time zones within seven days prior to screening.
- Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to Day 1.
- Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
- History of psychiatric disorder (including anxiety or depression) within the past 12 months.
- History of drug addiction or drug abuse within the past 12 months.
- History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, Text Revision and/or regularly consumes 4 or more alcoholic drinks per day.
- Current significant neurological (including psychiatric and cognitive disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to Day 1.
- Uses tobacco products during nightly awakenings.
- Used melatonin, or other drugs or supplements known to affect sleep/wake function within 1week (or 5 half lives of the drug, whichever is longer) prior to Day 1.
- Used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to Day 1. These medications must not have been used to treat psychiatric disorders.
- Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
- Any significant endocrine pathology based on borderline laboratory results.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (29)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Jasper, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Peoria, Arizona, United States
Unknown Facility
La Palma, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Austell, Georgia, United States
Unknown Facility
Roswell, Georgia, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Florence, Kentucky, United States
Unknown Facility
Wentzville, Missouri, United States
Unknown Facility
Kenilworth, New Jersey, United States
Unknown Facility
South Plainfield, New Jersey, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Ninety Six, South Carolina, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
San Angelo, Texas, United States
Unknown Facility
Wichita Falls, Texas, United States
Related Publications (1)
Richardson G, Wang-Weigand S. Effects of long-term exposure to ramelteon, a melatonin receptor agonist, on endocrine function in adults with chronic insomnia. Hum Psychopharmacol. 2009 Mar;24(2):103-11. doi: 10.1002/hup.993.
PMID: 19090503RESULT
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
March 12, 2008
First Posted
April 14, 2008
Study Start
January 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
February 28, 2012
Record last verified: 2012-02