Status:
COMPLETED
Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia
Lead Sponsor:
Sanofi
Conditions:
Fibromyalgia
Sleep
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 pat...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00313885
Start Date
April 1 2004
End Date
June 1 2005
Last Update
November 30 2010
Active Locations (12)
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1
Radiant Research
Phoenix, Arizona, United States, 85013
2
San Diego Arthritis Medical Clinic
San Diego, California, United States, 92108
3
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
4
Miami Research Assoc., Inc.
Miami, Florida, United States, 33173