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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00313885

Collaborator

(none)

205

Enrollment

Locations

Arms

Duration (Months)

17.1

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Sleep Chronic Pain	Drug: eplivanserin (SR46349) Drug: placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

205 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 1 mg daily	Drug: eplivanserin (SR46349) oral administration
Experimental: 2 5 mg daily	Drug: eplivanserin (SR46349) oral administration
Placebo Comparator: 3	Drug: placebo oral administration

Arm

Intervention/Treatment

Experimental: 1

1 mg daily

Drug: eplivanserin (SR46349)

oral administration

Experimental: 2

5 mg daily

Drug: eplivanserin (SR46349)

oral administration

Placebo Comparator: 3

Drug: placebo

oral administration

Outcome Measures

Primary Outcome Measures

refreshing quality of sleep measured by the patient sleep questionnaire [8 weeks]

Secondary Outcome Measures

sleep parameters (maintenance, duration, induction and quality) [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research	Phoenix	Arizona	United States	85013
2	San Diego Arthritis Medical Clinic	San Diego	California	United States	92108
3	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
4	Miami Research Assoc., Inc.	Miami	Florida	United States	33173
5	Renstar Medical Research	Ocala	Florida	United States	34471
6	Comprehensive Neuroscience	Atlanta	Georgia	United States	30328
7	Physicians Research Group	Indianapolis	Indiana	United States	46250
8	Wichita Clinic PA	Wichita	Kansas	United States	67208
9	Westroads Medical Group	Omaha	Nebraska	United States	68114
10	Physicians Research Options	Ogden	Utah	United States	84403
11	Seattle Rheumatology Assoc.	Seattle	Washington	United States	98104
12	Sanofi-Aventis Administrative Office	Laval		Canada