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

NCT ID: NCT00313885

Last Updated: 2010-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Fibromyalgia Sleep Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

1 mg daily

Group Type EXPERIMENTAL

eplivanserin (SR46349)

Intervention Type DRUG

oral administration

2

5 mg daily

Group Type EXPERIMENTAL

eplivanserin (SR46349)

Intervention Type DRUG

oral administration

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration

Interventions

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eplivanserin (SR46349)

oral administration

Intervention Type DRUG

placebo

oral administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Radiant Research

Phoenix, Arizona, United States

Site Status

San Diego Arthritis Medical Clinic

San Diego, California, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Miami Research Assoc., Inc.

Miami, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Comprehensive Neuroscience

Atlanta, Georgia, United States

Site Status

Physicians Research Group

Indianapolis, Indiana, United States

Site Status

Wichita Clinic PA

Wichita, Kansas, United States

Site Status

Westroads Medical Group

Omaha, Nebraska, United States

Site Status

Physicians Research Options

Ogden, Utah, United States

Site Status

Seattle Rheumatology Assoc.

Seattle, Washington, United States

Site Status

Sanofi-Aventis Administrative Office

Laval, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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ACT5400

Identifier Type: -

Identifier Source: org_study_id