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

November 29, 2010 updated by: Sanofi

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
refreshing quality of sleep measured by the patient sleep questionnaire
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
sleep parameters (maintenance, duration, induction and quality)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

April 7, 2006

First Submitted That Met QC Criteria

April 7, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 29, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT5400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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