Fibromyalgia, Sleep, Chronic Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
oral administration
DRUGplacebo
oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Each patient must fulfill the diagnosis criteria of fibromyalgia according to the American College of Rheumatology * Based on patient's information: * The patient must complain of unrefreshing sleep for at least 3 nights per week over the past month. * The patient spends at least 6.5 hours and not more than 9 hours, in bed, each night over the past 2 weeks. * Female patients of childbearing potential must have a confirmed negative pregnancy test at the end of the screening period and use an acceptable method of birth control throughout the study * Written, signed and dated informed consent must be obtained from each patient * Willing to abstain from taking any medication or treatment prohibited as per the protocol
Exclusion criteria
* Females who are lactating or pregnant * Night shift workers, and individuals who nap 3 or more times per week over the preceding month (nap: intentionally sleeping for more than 20 minutes during the day). * Consumption of beverage with caffeine (i.e. tea, coffee, or cola) comprising more than 2 cups or glasses per day * Past or Current medical history of any significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| refreshing quality of sleep measured by the patient sleep questionnaire | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| sleep parameters (maintenance, duration, induction and quality) | 8 weeks |
Countries
Canada, United States
Outcome results
None listed