FibromyalgiaPhase 3NCT00645398

A Study of the Efficacy and Safety of Pregabalin for the Treatment of 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 102 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Fibromyalgia
What is being tested?: Pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 751 participants
Where: 102 sitesUnited States
Study dates: Sep 2004to Jun 2005
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 who met the American College of Rheumatology (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 who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Who cannot join

Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
Patients with severe depression

Trial locations and contacts

102 sites in 1 country.

City, postcode or hospital

102 sites in 1 country

United States102 sites

Pfizer Investigational Site
Albany, New York, 12205
Pfizer Investigational Site
Altoona, Pennsylvania, 16601
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Anderson, South Carolina, 29621
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Beverly Hills, California, 90211
Pfizer Investigational Site
Birmingham, Alabama, 35294
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, 30033-5930
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
East Lansing, Michigan, 48823
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
Pfizer Investigational Site
Long Beach, California, 90806
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
Northridge, California, 91335
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, 66210
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410
Pfizer Investigational Site
Paradise Valley, Arizona, 85253
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, 85032
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
Plantation, Florida, 33317
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Portland, Oregon, 97201
Pfizer Investigational Site
Pottstown, Pennsylvania, 19610
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, 92501
Pfizer Investigational Site
Riverside, California, 92506
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
San Antonio, Texas, 78229-4540
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
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, 05091-0437
Pfizer Investigational Site
Woodstock, Vermont, 05091
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610
Pfizer Investigational Site
Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia

The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance 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
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
PregabalinDrug
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
PregabalinDrug
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
PlaceboDrug
Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

Study groups in NCT00645398
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Pregabalin
B	Experimental	Not described Receives: Drug: Pregabalin
C	Experimental	Not described Receives: Drug: Pregabalin
D	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Endpoint mean pain score derived from the subject's daily pain diary
Measured: Endpoint
Patient Global Assessment (Patient Global Impression of Change) at Termination Visit
Measured: Weeks 5 and 13
Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit
Measured: Baseline and Weeks 5, 9, and 13

Secondary outcomes (14)

Change from baseline in FIQ scores at Weeks 5, 9, and 13
Measured: Baseline and Weeks 5, 9, and 13
Change from baseline in SDS scores at Weeks 5, 9, and 13
Measured: Baseline and Weeks 5, 9, and 13
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13
Measured: Baseline and Weeks 5, 9, and 13
Quality of Sleep Score from the Daily Sleep Diary
Measured: Daily
Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13
Measured: Baseline and Weeks 5, 9, and 13
Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13
Measured: Baseline and Week 13
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13
Measured: Screening, baseline, and Weeks 5, 9, and 13
Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13
Measured: Baseline and Weeks 9 and 13
Adverse events
Measured: Weeks 1, 2, 5, 9, 13, and at follow-up
Physical examination, including vital signs and weight
Measured: Baseline and Week 5 (vital signs only) and 13
Neurological examination
Measured: Screening and Week 13
Electrocardiogram
Measured: Screening and Week 13
Laboratory tests, including chemistry and hematology
Measured: Baseline and Weeks 5, 13, and at follow-up
Urinalysis
Measured: Baseline and Weeks 13 and at follow-up

Timeline

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

Sep 2004Jun 2005

First posted27 Mar 2008 (estimated)
Study startSep 2004
Study completionJun 2005

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
Who is masked: Participant, Investigator
Enrolment: 751 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00645398
Sponsor's protocol ID: A0081056
Status last verified: Apr 2008
First submitted: 25 Mar 2008
Last updated: 25 Jan 2021
Results posted: No
Data monitoring committee: Yes

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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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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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Recruiting
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT00645398
Acronym / sponsor ID: A0081056
Conditions: Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 751 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2004
Study completion: Jun 2005 (actual)
First posted: 27 Mar 2008 (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 (participant, investigator)
Number of arms: 4

Arm	Type	Receives
A	Experimental	Drug: Pregabalin
B	Experimental	Drug: Pregabalin
C	Experimental	Drug: Pregabalin
D	Placebo comparator	Drug: Placebo

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 who met the American College of Rheumatology (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 who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Key exclusion criteria (3 listed)

Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
Patients with severe depression

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
PregabalinPregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).	Drug	B
PregabalinPregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).	Drug	A
PregabalinPregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).	Drug	C
PlaceboMatching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).	Drug	D

Primary outcome

Endpoint mean pain score derived from the subject's daily pain diary
Time frame: Endpoint
Patient Global Assessment (Patient Global Impression of Change) at Termination Visit
Time frame: Weeks 5 and 13
Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit
Time frame: Baseline and Weeks 5, 9, and 13

14 secondary outcomes

Change from baseline in FIQ scores at Weeks 5, 9, and 13
Time frame: Baseline and Weeks 5, 9, and 13
Change from baseline in SDS scores at Weeks 5, 9, and 13
Time frame: Baseline and Weeks 5, 9, and 13
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13
Time frame: Baseline and Weeks 5, 9, and 13
Quality of Sleep Score from the Daily Sleep Diary
Time frame: Daily
Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13
Time frame: Baseline and Weeks 5, 9, and 13
Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13
Time frame: Baseline and Week 13
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13
Time frame: Screening, baseline, and Weeks 5, 9, and 13
Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13
Time frame: Baseline and Weeks 9 and 13
Adverse events
Time frame: Weeks 1, 2, 5, 9, 13, and at follow-up
Physical examination, including vital signs and weight
Time frame: Baseline and Week 5 (vital signs only) and 13
Neurological examination
Time frame: Screening and Week 13
Electrocardiogram
Time frame: Screening and Week 13
Laboratory tests, including chemistry and hematology
Time frame: Baseline and Weeks 5, 13, and at follow-up
Urinalysis
Time frame: Baseline and Weeks 13 and at follow-up

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 25 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

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
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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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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

102 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 102 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 3 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 25 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 102 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. Some participants in this study may receive a placebo. 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?

Endpoint mean pain score derived from the subject's daily pain diary (time frame: Endpoint). The study lists 3 primary outcomes in all. 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 NCT00645398, 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 25 Jan 2021.