FibromyalgiaPhase 2/3NCT00424892
Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome
A Phase 2/3 study testing Desvenlafaxine Sustained Release in people with Fibromyalgia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 59 sites in United States.
Trial summary
The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Desvenlafaxine Sustained Release
- How many people
- 600 participants
- Where
- 59 sitesUnited States
- Study dates
- Start not givento Jun 2007
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.
- Women of childbearing potential must have a negative serum pregnancy test result at study start.
Who cannot join
- Presence of any new/and or clinically important medical condition that might compromise patient's safety.
- Use of prohibited treatment.
- Meets any of the exclusion criteria listed for study 3151A4-327.
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
Study site
Anaheim, California, 92801
Study site
Atlanta, Georgia, 30342
Study site
Austin, Texas, 78756
Study site
Boston, Massachusetts, 02115
Study site
Bristol, Tennessee, 37620
Study site
Brooksville, Florida, 34613
Study site
Charleston, South Carolina, 29407
Study site
Chattanooga, Tennessee, 37404
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45219
Study site
Clementon, New Jersey, 08021
Study site
Cromwell, Connecticut, 06416
Study site
Dallas, Texas, 75231
Study site
Dayton, Ohio, 45408
Study site
Decatur, Georgia, 30033
Study site
DeLand, Florida, 32720
Study site
Delray Beach, Florida, 33484
Study site
Denver, Colorado, 80218
Study site
Duncansville, Pennsylvania, 16635
Study site
Harleysville, Pennsylvania, 19438
Study site
Huntsville, Alabama, 35801
Study site
Indianapolis, Indiana, 46202
Study site
Jacksonville, Florida, 32216
Study site
Kansas City, Missouri, 64114
Study site
Lansing, Michigan, 48910
Study site
Las Vegas, Nevada, 89106
Study site
Lexington, Kentucky, 40509
Study site
Lexington, Kentucky, 40536
Study site
Memphis, Tennessee, 38119
Study site
Miami, Florida, 33143
Study site
Middleton, Wisconsin, 53562
Study site
Mobile, Alabama, 36608
Study site
Newton, Massachusetts, 02462
Study site
Oklahoma City, Oklahoma, 73103
Study site
Oklahoma City, Oklahoma, 73112
Study site
Palm Beach Gardens, Florida, 33418
Study site
Pembroke Pines, Florida, 33026
Study site
Philadelphia, Pennsylvania, 19149
Study site
Philadelphia, Pennsylvania, 19152
Study site
Phoenix, Arizona, 85016
Study site
Raleigh, North Carolina, 27612
Study site
Rockville, Maryland, 20852
Study site
Sacramento, California, 95825
Study site
San Antonio, Texas, 78205
Study site
San Diego, California, 92108
Study site
Santa Ana, California, 92705
Study site
Sellersville, Pennsylvania, 18960
Study site
Smyrna, Georgia, 30080
Study site
St Louis, Missouri, 63117
Study site
St. Petersburg, Florida, 33709
Study site
Summerville, South Carolina, 29485
Study site
Sunrise, Florida, 33351
Study site
Tamarac, Florida, 33321
Study site
Tampa, Florida, 33606
Study site
Tulsa, Oklahoma, 74104
Study site
Walnut Creek, California, 94598
Study site
Warwick, Rhode Island, 02886
Study site
West Reading, Pennsylvania, 19611
About this study
Official title: A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.
The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.
Read the detailed description
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.
- Conditions
- Fibromyalgia
- Being tested
- Desvenlafaxine Sustained Release
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desvenlafaxine Sustained ReleaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.
Secondary outcomes (1)
Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study completionJun 2007
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424892
- Sponsor's protocol ID
- 3151A4-330
- Status last verified
- Dec 2007
- First submitted
- 18 Jan 2007
- Last updated
- 6 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.
- ClinicalTrials.gov ID
- NCT00424892
- Acronym / sponsor ID
- 3151A4-330
- Conditions
- Fibromyalgia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Jan 2007 (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.
The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.
Detailed description
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.
- Women of childbearing potential must have a negative serum pregnancy test result at study start.
Key exclusion criteria (3 listed)
- Presence of any new/and or clinically important medical condition that might compromise patient's safety.
- Use of prohibited treatment.
- Meets any of the exclusion criteria listed for study 3151A4-327.
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 |
|---|---|---|
| Desvenlafaxine Sustained Release | Drug | – |
Primary outcome
The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.
1 secondary outcome
Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.
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 6 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Desvenlafaxine Sustained Release in people with Fibromyalgia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 59 sites in United States.
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 2 inclusion and 3 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 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.. 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 6 Dec 2007; AzTrials last refreshed its copy on 1 Nov 2026.