FibromyalgiaPhase 2NCT00313885
Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia
A Phase 2 study testing eplivanserin (SR46349) in people with Fibromyalgia and Sleep, run by Sanofi at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Fibromyalgia, Sleep, Chronic Pain
- What is being tested?
- eplivanserin (SR46349)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Apr 2004to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Comprehensive Neuroscience
Atlanta, Georgia, 30328
Physicians Research Group
Indianapolis, Indiana, 46250
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Miami Research Assoc., Inc.
Miami, Florida, 33173
Renstar Medical Research
Ocala, Florida, 34471
Physicians Research Options
Ogden, Utah, 84403
Westroads Medical Group
Omaha, Nebraska, 68114
Radiant Research
Phoenix, Arizona, 85013
San Diego Arthritis Medical Clinic
San Diego, California, 92108
Seattle Rheumatology Assoc.
Seattle, Washington, 98104
Wichita Clinic PA
Wichita, Kansas, 67208
About this study
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.
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.
Read the 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.
- Conditions
- Fibromyalgia, Sleep, Chronic Pain
- Being tested
- eplivanserin (SR46349), placebo
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eplivanserin (SR46349)Drug
oral administration
placeboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1 mg daily Receives: Drug: eplivanserin (SR46349) |
| 2 | Experimental | 5 mg daily Receives: Drug: eplivanserin (SR46349) |
| 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
refreshing quality of sleep measured by the patient sleep questionnaire
Measured: 8 weeks
Secondary outcomes (1)
sleep parameters (maintenance, duration, induction and quality)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startApr 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313885
- Sponsor's protocol ID
- ACT5400
- Status last verified
- Nov 2010
- First submitted
- 7 Apr 2006
- Last updated
- 30 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00313885
- Acronym / sponsor ID
- ACT5400
- Conditions
- Fibromyalgia, Sleep, Chronic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: eplivanserin (SR46349)1 mg daily |
| 2 | Experimental | Drug: eplivanserin (SR46349)5 mg daily |
| 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eplivanserin (SR46349)oral administration | Drug | 1, 2 |
| placebooral administration | Drug | 3 |
Primary outcome
refreshing quality of sleep measured by the patient sleep questionnaire
Time frame: 8 weeks
1 secondary outcome
sleep parameters (maintenance, duration, induction and quality)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eplivanserin (SR46349) in people with Fibromyalgia and Sleep, run by Sanofi at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
refreshing quality of sleep measured by the patient sleep questionnaire (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.