FibromyalgiaPhase 3NCT00151489

Safety and Efficacy 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 109 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 purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people. 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: 1,020 participants
Where: 109 sitesUnited States
Study dates: Apr 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

At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites
At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale

Who cannot join

Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)
Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.

Trial locations and contacts

109 sites in 1 country.

City, postcode or hospital

109 sites in 1 country

United States109 sites

Pfizer Investigational Site
Albany, New York, 12205
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Anniston, Alabama, 36207
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020
Pfizer Investigational Site
Birmingham, Alabama, 35235
Pfizer Investigational Site
Blue Springs, Missouri, 64014
Pfizer Investigational Site
Calera, Alabama, 35040
Pfizer Investigational Site
Carmichael, California, 95608
Pfizer Investigational Site
Charleston, South Carolina, 29406
Pfizer Investigational Site
Charleston, West Virginia, 25304
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Cherry Hill, New Jersey, 08002
Pfizer Investigational Site
Chiefland, Florida, 32680
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Columbus, Ohio, 43212
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Edison, New Jersey, 08817
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Evansville, Indiana, 47712
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Fayetteville, Arkansas, 72703
Pfizer Investigational Site
Fort Worth, Texas, 76107
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Greenville, South Carolina, 29601
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Henderson, Nevada, 89014
Pfizer Investigational Site
Highland Park, New Jersey, 08904
Pfizer Investigational Site
Hot Springs, Arkansas, 71913
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Indianapolis, Indiana, 46254
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Johnson City, New York, 13790
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Kissimmee, Florida, 34741
Pfizer Investigational Site
Lansing, Michigan, 48917
Pfizer Investigational Site
Layton, Utah, 84041
Pfizer Investigational Site
Layton, Utah, 841041
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lexington, Kentucky, 40536-0284
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Los Alamitos, California, 90720
Pfizer Investigational Site
Mechanicsburg, Pennsylvania, 17055
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
Mogadore, Ohio, 44260
Pfizer Investigational Site
Nashville, Tennessee, 37207
Pfizer Investigational Site
New Orleans, Louisiana, 70114
Pfizer Investigational Site
New Orleans, Louisiana, 70128
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Northridge, California, 91324
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Owensboro, Kentucky, 42303
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Palm Springs, Florida, 33461
Pfizer Investigational Site
Peoria, Illinois, 61614
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Pismo Beach, California, 93449
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15218
Pfizer Investigational Site
Plantation, Florida, 33317
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Prairie Village, Kansas, 66206
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
Ridgewood, New Jersey, 07450
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Santa Ana, California, 92705
Pfizer Investigational Site
Scottsdale, Arizona, 85251
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98122
Pfizer Investigational Site
Seattle, Washington, 98166-2967
Pfizer Investigational Site
Sioux Falls, South Dakota, 57105
Pfizer Investigational Site
Smithtown, New York, 11787-2817
Pfizer Investigational Site
South Eddison, New Jersey, 08817
Pfizer Investigational Site
South Jordan, Utah, 84095
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
Springfield, Massachusetts, 01107
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
Stratford, Connecticut, 06615
Pfizer Investigational Site
Sunrise, Florida, 33351
Pfizer Investigational Site
Tampa, Florida, 33609
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
Tuscaloosa, Alabama, 35406
Pfizer Investigational Site
Virginia Beach, Virginia, 23454
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
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
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Worcester, Massachusetts, 01610
Pfizer Investigational Site
Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated 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 (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale

Secondary outcomes (1)

To evaluate the efficacy of pregabalin (BID) compared with placebo treatment to relieve pain and to improve global assessment, functional status, sleep and fatigue associated with fibromyalgia using questionnaires. To evaluate the longterm safety

Timeline

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

Apr 2005Jun 2006

First posted9 Sep 2005 (estimated)
Study startApr 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,020 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00151489
Sponsor's protocol ID: A0081059
Status last verified: Sep 2006
First submitted: 7 Sep 2005
Last updated: 22 Jan 2021
Results posted: No

Publications

Pauer L, Atkinson G, Murphy TK, Petersel D, Zeiher B. Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. Clin J Pain. 2012 Sep;28(7):609-14. doi: 10.1097/AJP.0b013e31823dd315.
PubMed 22688598

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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Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in 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 Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia
ClinicalTrials.gov ID: NCT00151489
Acronym / sponsor ID: A0081059
Conditions: Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,020 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Apr 2005
Study completion: Jun 2006 (actual)
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: 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)

At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites
At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale

Key exclusion criteria (4 listed)

Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)
Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.

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 (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale

1 secondary outcome

To evaluate the efficacy of pregabalin (BID) compared with placebo treatment to relieve pain and to improve global assessment, functional status, sleep and fatigue associated with fibromyalgia using questionnaires. To evaluate the longterm safety

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 22688598Pauer L, Atkinson G, Murphy TK, Petersel D, Zeiher B. Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. Clin J Pain. 2012 Sep;28(7):609-14. doi: 10.1097/AJP.0b013e31823dd315.
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

109 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 109 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 4 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 109 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 (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale. 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 NCT00151489, 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.