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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00313885

Public ClinicalTrials.gov record NCT00313885. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 9:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00313885
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
205 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2004 (Type not available)
Primary completion
Jun 2005 (Actual)
Completion
Jun 2005 (Actual)
Last update posted
Nov 30, 2010

2004 – 2005

United States locations

U.S. sites
11
U.S. states
9
U.S. cities
11
Facility City State ZIP Site status
Radiant Research Phoenix Arizona 85013 —
San Diego Arthritis Medical Clinic San Diego California 92108 —
Jacksonville Center for Clinical Research Jacksonville Florida 32216 —
Miami Research Assoc., Inc. Miami Florida 33173 —
Renstar Medical Research Ocala Florida 34471 —
Comprehensive Neuroscience Atlanta Georgia 30328 —
Physicians Research Group Indianapolis Indiana 46250 —
Wichita Clinic PA Wichita Kansas 67208 —
Westroads Medical Group Omaha Nebraska 68114 —
Physicians Research Options Ogden Utah 84403 —
Seattle Rheumatology Assoc. Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00313885, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 30, 2010 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00313885 live on ClinicalTrials.gov.

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