FibromyalgiaPhase 3NCT00151528

An Open-Label Trial of Pregabalin in Patients With 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 93 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy. 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: 428 participants
Where: 93 sitesUnited States
Study dates: Jan 2005to Jun 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 have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
Must have received pregabalin/placebo under double-blind conditions.

Who cannot join

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.

Trial locations and contacts

93 sites in 1 country.

City, postcode or hospital

93 sites in 1 country

United States93 sites

Pfizer Investigational Site
Albany, New York, 12205
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Anderson, South Carolina, 29621
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Beverly Hills, California, 90211
Pfizer Investigational Site
Birmingham, Alabama, 35294-3405
Pfizer Investigational Site
Birmingham, Alabama, 35294-6909
Pfizer Investigational Site
Boise, Idaho, 83704
Pfizer Investigational Site
Charleston, South Carolina, 29406
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Columbus, Ohio, 43124
Pfizer Investigational Site
Columbus, Ohio, 43212
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Danbury, Connecticut, 06810
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Hot Springs, Arkansas, 71913
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Johnstown, Pennsylvania, 15904
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Kansas City, Kansas, 66160
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Lansing, Michigan, 48917
Pfizer Investigational Site
Lebanon, New Hampshire, 03766
Pfizer Investigational Site
Little Rock, Arkansas, 72205-7101
Pfizer Investigational Site
Los Alamitos, California, 90720
Pfizer Investigational Site
Lubbock, Texas, 79424
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Mechanicsburg, Pennsylvania, 17055
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
Mogadore, Ohio, 44260
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Milford, Connecticut, 06776
Pfizer Investigational Site
New Orleans, Louisiana, 70114
Pfizer Investigational Site
New York, New York, 10003
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
Newton, Massachusetts, 02462
Pfizer Investigational Site
Northridge, California, 91324-4625
Pfizer Investigational Site
Oak Brook, Illinois, 60523
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73109
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410
Pfizer Investigational Site
Peoria, Illinois, 61614
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19115
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19146
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Phoenix, Arizona, 85050
Pfizer Investigational Site
Pismo Beach, California, 93449
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15218
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15224
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Pottstown, Pennsylvania, 19464
Pfizer Investigational Site
Princeton, New Jersey, 08540
Pfizer Investigational Site
Redondo Beach, California, 90277
Pfizer Investigational Site
Richardson, Texas, 75080
Pfizer Investigational Site
Riverside, California, 92506
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
San Antonio, Texas, 78229-4548
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Scottsdale, Arizona, 85254
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98122
Pfizer Investigational Site
Seminole, Florida, 33708
Pfizer Investigational Site
St. Petersburg, Florida, 33703
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
St. Petersburg, Florida, 33710
Pfizer Investigational Site
Stratford, Connecticut, 06615
Pfizer Investigational Site
Sunrise, Florida, 33351-6637
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Virginia Beach, Virginia, 23454
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
West Palm Beach, Florida, 33409
Pfizer Investigational Site
West Reading, Pennsylvania, 19611-1124
Pfizer Investigational Site
Whittier, California, 90601
Pfizer Investigational Site
Wilmington, North Carolina, 28401
Pfizer Investigational Site
Wilmington, North Carolina, 28403
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Woodstock, Vermont, 05091
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610
Pfizer Investigational Site
Yakima, Washington, 98902

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About this study

Official title: A Long-Term, Open-Label, Safety Trial 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.

Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.

Secondary outcomes (1)

There are no secondary outcome measures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Jun 2006

First posted9 Sep 2005 (estimated)
Study startJan 2005
Study completionJun 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: 428 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00151528
Sponsor's protocol ID: A0081057
Status last verified: Jul 2006
First submitted: 7 Sep 2005
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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All Fibromyalgia trials

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 Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT00151528
Acronym / sponsor ID: A0081057
Conditions: Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 428 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jan 2005
Study completion: Jun 2006
First posted: 9 Sep 2005 (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.

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 have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
Must have received pregabalin/placebo under double-blind conditions.

Key exclusion criteria (1 listed)

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.

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

Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.

1 secondary outcome

There are no secondary outcome measures

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

93 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 93 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 93 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?

Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.. 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 NCT00151528, 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.