NCT00313885

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
Last Updated

November 30, 2010

Status Verified

November 1, 2010

Enrollment Period

1.2 years

First QC Date

April 7, 2006

Last Update Submit

November 29, 2010

Conditions

FibromyalgiaSleepChronic Pain

Outcome Measures

Primary Outcomes (1)

  • refreshing quality of sleep measured by the patient sleep questionnaire

    8 weeks

Secondary Outcomes (1)

  • sleep parameters (maintenance, duration, induction and quality)

    8 weeks

Study Arms (3)

1

EXPERIMENTAL

1 mg daily

Drug: eplivanserin (SR46349)

2

EXPERIMENTAL

5 mg daily

Drug: eplivanserin (SR46349)

3

PLACEBO COMPARATOR
Drug: placebo

Interventions

eplivanserin (SR46349)DRUG

oral administration

12
placeboDRUG

oral administration

3

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Radiant Research

Phoenix, Arizona, 85013, United States

Location

San Diego Arthritis Medical Clinic

San Diego, California, 92108, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Miami Research Assoc., Inc.

Miami, Florida, 33173, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Comprehensive Neuroscience

Atlanta, Georgia, 30328, United States

Location

Physicians Research Group

Indianapolis, Indiana, 46250, United States

Location

Wichita Clinic PA

Wichita, Kansas, 67208, United States

Location

Westroads Medical Group

Omaha, Nebraska, 68114, United States

Location

Physicians Research Options

Ogden, Utah, 84403, United States

Location

Seattle Rheumatology Assoc.

Seattle, Washington, 98104, United States

Location

Sanofi-Aventis Administrative Office

Laval, Canada

Location

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Interventions

SR 46349B

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 12, 2006

Study Start

April 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 30, 2010

Record last verified: 2010-11

Locations

US(11)CA(1)