Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia

Completed · Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia, Sleep, Chronic Pain

In brief

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.

Key facts

Study ID

NCT00313885

Run by

Sanofi

People needed

205

Starts

2004-04-01

Expected to finish

2005-06-01

Last updated by the study team

2010-11-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Miami Research Assoc., Inc. — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Comprehensive Neuroscience — Atlanta, Georgia, United States
• Physicians Research Group — Indianapolis, Indiana, United States
• Wichita Clinic PA — Wichita, Kansas, United States
• Westroads Medical Group — Omaha, Nebraska, United States
• Physicians Research Options — Ogden, Utah, United States
• Seattle Rheumatology Assoc. — Seattle, Washington, United States
• Sanofi-Aventis Administrative Office — Laval, Canada

Full record on ClinicalTrials.gov

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