FibromyalgiaPhase 3NCT00282997
A Safety Study Of Pregabalin In Fibromyalgia
A Phase 3 study testing pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 72 sites in United States.
Trial summary
To evaluate the safety of pregabalin in patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- pregabalin
- How many people
- 500 participants
- Where
- 72 sitesUnited States
- Study dates
- Feb 2006to Oct 2006
- Phase
- Phase 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
- Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
- Patients must complete the double-blind study.
Who cannot join
- Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
United States72 sites
Pfizer Investigational Site
Albany, New York
Pfizer Investigational Site
Asheville, North Carolina
Pfizer Investigational Site
Bedford, Texas
Pfizer Investigational Site
Bethlehem, Pennsylvania
Pfizer Investigational Site
Chaska, Minnesota
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Dayton, Ohio
Pfizer Investigational Site
DeLand, Florida
Pfizer Investigational Site
Dubuque, Iowa
Pfizer Investigational Site
Endwell, New York
Pfizer Investigational Site
Everett, Washington
Pfizer Investigational Site
Fresno, California
Pfizer Investigational Site
Gainesville, Florida
Pfizer Investigational Site
Georgetown, Texas
Pfizer Investigational Site
Goose Creek, South Carolina
Pfizer Investigational Site
Gurnee, Illinois
Pfizer Investigational Site
Hickory, North Carolina
Pfizer Investigational Site
Hollywood, Florida
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Indianapolis, Indiana
Pfizer Investigational Site
Jefferson City, Missouri
Pfizer Investigational Site
Kansas City, Missouri
Pfizer Investigational Site
Kenner, Louisiana
Pfizer Investigational Site
Killeen, Texas
Pfizer Investigational Site
Knoxville, Tennessee
Pfizer Investigational Site
La Jolla, California
Pfizer Investigational Site
Lake Jackson, Texas
Pfizer Investigational Site
Lexington, Kentucky
Pfizer Investigational Site
Lincoln, Nebraska
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Melbourne, Florida
Pfizer Investigational Site
Metairie, Louisiana
Pfizer Investigational Site
Milan, Tennessee
Pfizer Investigational Site
Milwaukee, Wisconsin
Pfizer Investigational Site
Minot, North Dakota
Pfizer Investigational Site
Moline, Illinois
Pfizer Investigational Site
Morristown, New Jersey
Pfizer Investigational Site
Mt. Pleasant, South Carolina
Pfizer Investigational Site
Myrtle Beach, South Carolina
Pfizer Investigational Site
Nashville, Tennessee
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Newark, Delaware
Pfizer Investigational Site
Norristown, Pennsylvania
Pfizer Investigational Site
North Dartmouth, Massachusetts
Pfizer Investigational Site
Northridge, California
Pfizer Investigational Site
Ocala, Florida
Pfizer Investigational Site
Palm Harbor, Florida
Pfizer Investigational Site
Pismo Beach, California
Pfizer Investigational Site
Prairie Village, Kansas
Pfizer Investigational Site
Pratt, Kansas
Pfizer Investigational Site
Raleigh, North Carolina
Pfizer Investigational Site
Sacramento, California
Pfizer Investigational Site
Saint Paul, Minnesota
Pfizer Investigational Site
Salisbury, North Carolina
Pfizer Investigational Site
Salt Lake City, Utah
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Diego, California
Pfizer Investigational Site
Spokane, Washington
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
Summerville, South Carolina
Pfizer Investigational Site
Sunrise, Florida
Pfizer Investigational Site
Tacoma, Washington
Pfizer Investigational Site
Tampa, Florida
Pfizer Investigational Site
Tulsa, Oklahoma
Pfizer Investigational Site
Virginia Beach, Virginia
Pfizer Investigational Site
Walnut Creek, California
Pfizer Investigational Site
Watertown, Massachusetts
Pfizer Investigational Site
West Palm Beach, Florida
Pfizer Investigational Site
West Seneca, New York
Pfizer Investigational Site
Winston-Salem, North Carolina
Pfizer Investigational Site
Woodstock, Vermont
Pfizer Investigational Site
Worcester, Massachusetts
About this study
Official title: A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
To evaluate the safety of pregabalin in patients with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- pregabalin
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of pregabalin in patients with fibromyalgia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startFeb 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282997
- Sponsor's protocol ID
- A0081078
- Status last verified
- Oct 2007
- First submitted
- 26 Jan 2006
- Last updated
- 22 Jan 2021
- Results posted
- No
Publications
Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.
PubMed 22503162
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00282997
- Acronym / sponsor ID
- A0081078
- Conditions
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Oct 2006 (actual)
- First posted
- 27 Jan 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.
To evaluate the safety of pregabalin in patients with fibromyalgia.
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)
- Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
- Patients must complete the double-blind study.
Key exclusion criteria (1 listed)
- Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.
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 |
|---|---|---|
| pregabalin | Drug | – |
Primary outcome
To evaluate the safety of pregabalin in patients with fibromyalgia
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 22 Jan 2021.
- Derived from this study: PubMed 22503162Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Pfizer CT.gov Call Center study director
Pfizer
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 72 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 1 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 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 phase mean?
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?
To evaluate the safety of pregabalin in patients with fibromyalgia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00282997, which also lists 1 linked publication.
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 22 Jan 2021.