Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00313885

Purpose

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.

Condition	Intervention	Phase
Fibromyalgia Sleep Chronic Pain	Drug: eplivanserin (SR46349) Drug: placebo	Phase II

MedlinePlus related topics: Fibromyalgia Sleep Disorders

Drug Information available for: Eplivanserin SR 46349B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

refreshing quality of sleep measured by the patient sleep questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

sleep parameters (maintenance, duration, induction and quality) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	205
Study Start Date:	April 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1 mg daily	Drug: eplivanserin (SR46349) oral administration
2: Experimental 5 mg daily	Drug: eplivanserin (SR46349) oral administration
3: Placebo Comparator	Drug: placebo oral administration

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

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313885

Locations

United States, Arizona
Radiant Research
Phoenix, Arizona, United States, 85013
United States, California
San Diego Arthritis Medical Clinic
San Diego, California, United States, 92108
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
Miami Research Assoc., Inc.
Miami, Florida, United States, 33173
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
United States, Georgia
Comprehensive Neuroscience
Atlanta, Georgia, United States, 30328
United States, Indiana
Physicians Research Group
Indianapolis, Indiana, United States, 46250
United States, Kansas
Wichita Clinic PA
Wichita, Kansas, United States, 67208
United States, Nebraska
Westroads Medical Group
Omaha, Nebraska, United States, 68114
United States, Utah
Physicians Research Options
Ogden, Utah, United States, 84403
United States, Washington
Seattle Rheumatology Assoc.
Seattle, Washington, United States, 98104
Canada
Sanofi-Aventis Administrative Office
Laval, Canada

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	ACT5400
Study First Received:	April 7, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00313885
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Fibromyalgia
Myofascial Pain Syndromes
Sleep Disorders
Pain
Rheumatic Diseases
Serotonin
Signs and Symptoms

Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Mental Disorders
SR 46349B
Neurologic Manifestations

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Cardiovascular Agents

Pharmacologic Actions
Fibrin Modulating Agents
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009