Chronic Insomnia Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
A vast majority of people are affected by chronic insomnia in the western world. Several
studies have looked at this and have estimated that 30% to 48% of the general population is
affected at some time in their life with a form of insomnia that goes on for several months,
and about one third of those are described as severely affected. Daytime symptoms of
insomnia include tiredness, lack of energy, difficulty concentrating, and irritability.
Recent epidemiologic research focusing on the quality of life has identified significant
insomnia-related conditions that relate to work productivity, health care utilization, and
risk of depression. Insomnia is associated with diminished work output, absenteeism, and
greater rates of accidents.
An ideal treatment for chronic insomnia would include administration of therapy for an
extended period. Specifically, it should be safe and effective for a period longer than the
7 to 10 days to which use of the current drugs approved for short-term use are limited.
Because of the absence of evidence of residual effects in pre-clinical studies and phase 2
and 3 clinical trials, ramelteon may be a candidate for extended use. As chronic insomnia
becomes more prevalent, there is a need to assess the long-term efficacy and safety of
nightly dosing with ramelteon in the general population. Study participation is anticipated
to be about 8 months and 3 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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