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

Chronic Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313885
• Other study ID #: ACT5400
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2006
• Last updated: November 29, 2010
• Start date: April 2004
• Est. completion date: June 2005

Study information

• Verified date: November 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes
• Parasomnias
• Sleep
• Sleep Disorders

Intervention

Drug:
• eplivanserin (SR46349)
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval
United States	Comprehensive Neuroscience	Atlanta	Georgia
United States	Physicians Research Group	Indianapolis	Indiana
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	Physicians Research Options	Ogden	Utah
United States	Westroads Medical Group	Omaha	Nebraska
United States	Radiant Research	Phoenix	Arizona
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	Seattle Rheumatology Assoc.	Seattle	Washington
United States	Wichita Clinic PA	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	refreshing quality of sleep measured by the patient sleep questionnaire		8 weeks	No
Secondary	sleep parameters (maintenance, duration, induction and quality)		8 weeks	No