Clinical trial NCT00313885: Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Sleep
Chronic Pain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: refreshing quality of sleep measured by the patient sleep questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: sleep parameters (maintenance, duration, induction and quality)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Radiant Research
state: Arizona
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Research Assoc., Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Atlanta
country: United States
facility: Comprehensive Neuroscience
state: Georgia
city: Indianapolis
country: United States
facility: Physicians Research Group
state: Indiana
city: Wichita
country: United States
facility: Wichita Clinic PA
state: Kansas
city: Omaha
country: United States
facility: Westroads Medical Group
state: Nebraska
city: Ogden
country: United States
facility: Physicians Research Options
state: Utah
city: Seattle
country: United States
facility: Seattle Rheumatology Assoc.
state: Washington
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: