Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Insomnia

In brief

This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once daily (QD), in elderly participants with chronic insomnia.

Key facts

Study ID

NCT00671255

Run by

Takeda

People needed

829

Starts

2002-12-01

Expected to finish

2004-01-01

Last updated by the study team

2012-02-28

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is a male or a post-menopausal female.
• Primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep.
• Subjective sleep latency greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours per night for at least 3 nights during the week of the lead-in period.
• Habitual bedtime is between 8:30 PM and 12:00 AM.
• Body mass index between 18 and 34, inclusive.

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 took any investigational drug within 30 days or five half-lives prior to the first day of single-blind study medication, whichever is longer.
• Sleep schedule changes required by employment (eg, shift worker) within three months prior to the first day of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.
• Participated in a weight loss program or substantially altered exercise routine within 30 days prior to the first day of single blind study medication.
• Has 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 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 the 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, unless currently controlled and stable with protocol-allowed medication.
• Uses tobacco products during nightly awakenings.
• Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
• Positive hepatitis panel.
• Any additional condition(s) that in the Investigator's opinion would:
• affect sleep-wake function
• prohibit the subject from completing the study
• not be in the best interest of the subject.
• Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
• Anxiolytics
• Hypnotics
• Antidepressants
• Anticonvulsants
• Sedating H1 antihistamines
• Systemic steroids
• Respiratory stimulants

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Tallahassee, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Encinitas, California, United States
• Study site — Irvine, California, United States
• Study site — La Jolla, California, United States
• Study site — La Mesa, California, United States
• Study site — Los Angeles, California, United States
• Study site — Murrieta, California, United States
• Study site — Northridge, California, United States
• Study site — Oakland, California, United States
• Study site — Redlands, California, United States
• Study site — Riverside, California, United States
• Study site — Rosemead, California, United States
• Study site — San Diego, California, United States
• Study site — Spring Valley, California, United States
• Study site — Vista, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Columbiana, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.