Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. By improving the quality of sleep, complaints of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this chronic pain disorder may be improved.
The purpose of this research study is to investigate the effectiveness and safety of 2 doses of the investigational product in subjects with sleep disorders with fibromyalgia as compared to placebo (a substance which contains no active ingredient). The study will last approximately 70 days and will include 7 office visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
205
oral administration
oral administration
Radiant Research
Phoenix, Arizona, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
refreshing quality of sleep measured by the patient sleep questionnaire
Time frame: 8 weeks
sleep parameters (maintenance, duration, induction and quality)
Time frame: 8 weeks
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