FibromyalgiaPhase 2/3NCT00301431
Study Evaluating the Efficacy of DVS-233 in Fibromyalgia
A Phase 2/3 study testing DVS-233 in people with Fibromyalgia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 59 sites in United States.
Trial summary
The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of 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?
- DVS-233
- How many people
- 1,050 participants
- Where
- 59 sitesUnited States
- Study dates
- Aug 2006to 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
- Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria
Who cannot join
- Other painful conditions that may make results difficult to interpret.
- Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.
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, 33613
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
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DeLand, Florida, 32720
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Delray Beach, Florida, 33484
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Denver, Colorado, 80218
Study site
Duncansville, Pennsylvania, 16635
Study site
Harleysville, Pennsylvania, 19438
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Huntsville, Alabama, 35801
Study site
Indianapolis, Indiana, 46202
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Jacksonville, Florida, 32216
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Kansas City, Missouri, 64114
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Lansing, Michigan, 48910
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Las Vegas, Nevada, 89106
Study site
Lexington, Kentucky, 40509
Study site
Lexington, Kentucky, 40536-0284
Study site
Memphis, Tennessee, 38119
Study site
Miami, Florida, 33173
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, 33351-6637
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design, Efficacy and Tolerability Study of 4 Fixed Doses of DVS-233 in Adult Outpatients With Fibromyalgia Syndrome
The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of fibromyalgia syndrome.
- Conditions
- Fibromyalgia
- Being tested
- DVS-233
- Keywords
- Fibromyalgia, Adults, Outpatients, Adult, Double-Blind Method
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVS-233Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
Secondary outcomes (1)
Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startAug 2006
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,050 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
- NCT00301431
- Sponsor's protocol ID
- 3151A4-327
- Status last verified
- Dec 2007
- First submitted
- 8 Mar 2006
- Last updated
- 5 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design, Efficacy and Tolerability Study of 4 Fixed Doses of DVS-233 in Adult Outpatients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT00301431
- Acronym / sponsor ID
- 3151A4-327
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Adults, Outpatients, Adult, Double-Blind Method
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,050 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Mar 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.
The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of fibromyalgia syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria
Key exclusion criteria (2 listed)
- Other painful conditions that may make results difficult to interpret.
- Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.
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 |
|---|---|---|
| DVS-233 | Drug | – |
Primary outcome
The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
1 secondary outcome
Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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 DVS-233 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 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 was stopped early. Results are not available in the source record.
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 primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.. 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 5 Dec 2007.