FibromyalgiaPhase 3NCT00230776

A Controlled Pregabalin Trial 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 89 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

To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 740 participants
Where: 89 sitesUnited States
Study dates: Oct 2005to Jul 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 have a score of >40 mm on the Visual Analog Scale

Who cannot join

Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.

Trial locations and contacts

89 sites in 1 country.

City, postcode or hospital

89 sites in 1 country

United States89 sites

Pfizer Investigational Site
Albany, New York, 12205
Pfizer Investigational Site
Allentown, Pennsylvania, 18103
Pfizer Investigational Site
Asheville, North Carolina, 28801
Pfizer Investigational Site
Bedford, Texas, 76021
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Chattanooga, Tennessee, 37404
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Cincinnati, Ohio, 45245
Pfizer Investigational Site
Dayton, Ohio, 45402
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Dubuque, Iowa, 52001
Pfizer Investigational Site
Dubuque, Iowa, 52002
Pfizer Investigational Site
Endwell, New York, 13760
Pfizer Investigational Site
Everett, Washington, 98201
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Gainesville, Florida, 32610-0221
Pfizer Investigational Site
Georgetown, Texas, 78626
Pfizer Investigational Site
Goose Creek, South Carolina, 29445
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Hickory, North Carolina, 28601
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Hollywood, Florida, 33023
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Indianapolis, Indiana, 46202-5250
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Kansas City, Missouri, 64106
Pfizer Investigational Site
Kenner, Louisiana, 70065
Pfizer Investigational Site
Killeen, Texas, 76549
Pfizer Investigational Site
Knoxville, Tennessee, 37909-1900
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Lansing, Michigan, 48910
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lincoln, Nebraska, 68516
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Milan, Tennessee, 38358
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Minot, North Dakota, 58701
Pfizer Investigational Site
Moline, Illinois, 61265
Pfizer Investigational Site
Morristown, New Jersey, 07960
Pfizer Investigational Site
Morton Grove, Illinois, 60053
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Myrtle Beach, South Carolina, 29572
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New York, New York, 10022-1009
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Norristown, Pennsylvania, 19401
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Northridge, California, 91325
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Pismo Beach, California, 93449
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15218
Pfizer Investigational Site
Prairie Village, Kansas, 66206
Pfizer Investigational Site
Pratt, Kansas, 67124
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
Saint Paul, Minnesota, 55101
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
Salt Lake City, Utah, 84102-1571
Pfizer Investigational Site
San Antonio, Texas, 78213
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
Spokane, Washington, 99216
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Summerville, South Carolina, 29485
Pfizer Investigational Site
Sunrise, Florida, 33351
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Tulsa, Oklahoma, 74104-5428
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Watertown, Massachusetts, 02472
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
West Seneca, New York, 14224
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Woodstock, Vermont, 05091
Pfizer Investigational Site
Worcester, Massachusetts, 01610

Other trials in United States

About this study

Official title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia

To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia

Conditions: Fibromyalgia
Being tested: pregabalin, placebo
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pregabalinDrug
placeboDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Secondary outcomes (1)

To evaluate the efficacy of pregabalin for improvement in sleep, fatigue, health-related quality of life, functioning and mood disturbance associated with fibromyalgia. To evaluate safety and tolerability.

Timeline

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

Oct 2005Jul 2006

First posted3 Oct 2005 (estimated)
Study startOct 2005
Study completionJul 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 740 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00230776
Sponsor's protocol ID: A0081077
Status last verified: Oct 2012
First submitted: 29 Sep 2005
Last updated: 26 Jan 2021
Results posted: No

Publications

Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.
PubMed 26694975
Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.
PubMed 21639874
Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.
PubMed 21039311

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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Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
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Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Chronic Low-back Pain, Chronic Pain
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome

All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT00230776
Acronym / sponsor ID: A0081077
Conditions: Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 740 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2005
Study completion: Jul 2006 (actual)
First posted: 3 Oct 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.

To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia

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 (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 have a score of >40 mm on the Visual Analog Scale

Key exclusion criteria (1 listed)

Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.

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	–
placebo	Drug	–

Primary outcome

To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

1 secondary outcome

To evaluate the efficacy of pregabalin for improvement in sleep, fatigue, health-related quality of life, functioning and mood disturbance associated with fibromyalgia. To evaluate safety and tolerability.

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 26 Jan 2021.
Derived from this study: PubMed 26694975Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.
Derived from this study: PubMed 21639874Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.
Derived from this study: PubMed 21039311Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Fibromyalgia

Recruiting
Light Bulb Stimuli to Reduce Chronic Pain
Fibromyalgia, Musculoskeletal Pain
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Recruiting
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Chronic Low-back Pain, Chronic Pain
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain 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

89 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 89 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 26 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 89 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 efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.. 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 NCT00230776, which also lists 3 linked publications.

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 26 Jan 2021.