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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: SR 46349B

Criteria

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