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

CompletedPhase 2NCT00313885
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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.

Study details

Official title
Efficacy and Safety of SR46349B (1 and 5mg/Day) Administered During 8 Weeks in Patients With Sleep Disorders in Fibromyalgia: Multi-center, Randomized, Double-blind, Placebo-controlled Study.
Interventions
Sponsor
Sanofi
Start date
2004-04
Primary completion
2005-06
Sex
All
Age range
from 18 Years to 64 Years
Results posted
No results posted in this snapshot
Countries
Canada, United States
Total sites listed
12

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Canadian sites (1)

FacilityCityProvince
Sanofi-Aventis Administrative OfficeLaval

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00313885