FibromyalgiaPhase 3NCT00612170

A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

A Phase 3 study testing [S,S]-Reboxetine in people with Fibromyalgia, run by Pfizer at 145 sites in 2 countries.

Completed

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

Trial summary

This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fibromyalgia
What is being tested?: [S,S]-Reboxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,129 participants
Where: 145 sitesin 2 countries
Study dates: Dec 2007to May 2009
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

Male or female of any race, at least 18 years of age
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)

Who cannot join

Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features

Trial locations and contacts

145 sites in 2 countries.

Country

City, postcode or hospital

145 sites in 2 countries

United States136 sites

Pfizer Investigational Site
Albany, New York, 12205
Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Ann Arbor, Michigan, 48103
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Aurora, Illinois, 60504
Pfizer Investigational Site
Austin, Texas, 78758
Pfizer Investigational Site
Austin, Texas, 78759
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Beaumont, Texas, 77706
Pfizer Investigational Site
Bend, Oregon, 97701
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015
Pfizer Investigational Site
Birmingham, Alabama, 35242
Pfizer Investigational Site
Boston, Massachusetts, 02135
Pfizer Investigational Site
Bridgeville, Pennsylvania, 15017
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Brockton, Massachusetts, 02301
Pfizer Investigational Site
Brooklyn, New York, 11235
Pfizer Investigational Site
Brooksville, Florida, 34601
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Carmichael, California, 95608
Pfizer Investigational Site
Chandler, Arizona, 85225
Pfizer Investigational Site
Charleston, South Carolina, 29412
Pfizer Investigational Site
Charlotte, North Carolina, 28209-3734
Pfizer Investigational Site
Charlottesville, Virginia, 22911
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Cincinnati, Ohio, 45249
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Columbia, Missouri, 65203
Pfizer Investigational Site
Columbia, Missouri, 65212
Pfizer Investigational Site
Columbus, Ohio, 43213
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
DeSoto, Texas, 75115
Pfizer Investigational Site
Dubuque, Iowa, 52001
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Elk Grove, California, 95758
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Fall River, Massachusetts, 02720
Pfizer Investigational Site
Fullerton, California, 92835
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Henderson, Nevada, 89014
Pfizer Investigational Site
Henderson, Nevada, 89015
Pfizer Investigational Site
Houston, Texas, 77063
Pfizer Investigational Site
Huntsville, Alabama, 35802
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Jackson, Tennessee, 38305
Pfizer Investigational Site
Jacksonville, Florida, 32205
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Jacksonville, Florida, 32223
Pfizer Investigational Site
Jacksonville, Florida, 32257
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Kirkland, Washington, 98033
Pfizer Investigational Site
Lafayette, California, 94549
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Las Vegas, Nevada, 89119
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Louisville, Kentucky, 40213
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Milan, Tennessee, 38358
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Moline, Illinois, 61265
Pfizer Investigational Site
Mount Sterling, Kentucky, 40353
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
Nassau Bay, Texas, 77058
Pfizer Investigational Site
New London, Connecticut, 06320
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
New York, New York, 10022-1009
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Northridge, California, 91325
Pfizer Investigational Site
Oak Brook, Illinois, 60523
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Ogden, Utah, 84405
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73103
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Omaha, Nebraska, 68134
Pfizer Investigational Site
Oregon, Wisconsin, 53575
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15216
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15243
Pfizer Investigational Site
Portland, Oregon, 97219
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Pratt, Kansas, 67124
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Rochester, New York, 14610
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Roseville, California, 95661
Pfizer Investigational Site
Sacramento, California, 95816
Pfizer Investigational Site
Sacramento, California, 95823
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
San Antonio, Texas, 78213
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Jose, California, 95124
Pfizer Investigational Site
Santa Ana, California, 92705
Pfizer Investigational Site
Sarasota, Florida, 34233
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98122
Pfizer Investigational Site
Spokane, Washington, 99216
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
Sunrise, Florida, 33351
Pfizer Investigational Site
Tallassee, Alabama, 36078
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
The Bronx, New York, 10454
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Tucson, Arizona, 85741
Pfizer Investigational Site
Venice, Florida, 34292
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
Watertown, Massachusetts, 02472
Pfizer Investigational Site
Wellesley Hills, Massachusetts, 02481-2106
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
West Reading, Pennsylvania, 19611-1124
Pfizer Investigational Site
Wheaton, Maryland, 20902
Pfizer Investigational Site
Willow Grove, Pennsylvania, 19090
Pfizer Investigational Site
Winter Haven, Florida, 33880
Pfizer Investigational Site
Worcester, Massachusetts, 01610

Other trials in United States

Canada9 sites

Pfizer Investigational Site
Bathurst, New Brunswick, E2A 4X7
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4
Pfizer Investigational Site
Moncton, New Brunswick, E1G 1A7
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 3J1
Pfizer Investigational Site
Québec, Quebec, G1V 3M7
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Pfizer Investigational Site
Toronto, Ontario, M3H 5S4
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia

Conditions: Fibromyalgia
Being tested: [S,S]-Reboxetine, Placebo
Keywords: Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia
Medical subject headings: Fibromyalgia

What participants receive

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

[S,S]-ReboxetineDrug
10 mg oral tablet once a day dosing
PlaceboDrug
0 mg oral tablet once a day dosing
[S,S]-ReboxetineDrug
4 mg oral tablet once a day dosing
[S,S]-ReboxetineDrug
8 mg oral tablet once a day dosing

Study groups in NCT00612170
Study group	Role	What they receive
3	Experimental	Not described Receives: Drug: [S,S]-Reboxetine
4	Sham comparator	Not described Receives: Drug: Placebo
1	Experimental	Not described Receives: Drug: [S,S]-Reboxetine
2	Experimental	Not described Receives: Drug: [S,S]-Reboxetine

What is being measured

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

Change from baseline in the endpoint mean pain score
Measured: 14 weeks
Fibromyalgia Impact Questionnaire
Measured: 14 weeks

Secondary outcomes (7)

Change from baseline in the endpoint mean sleep interference score
Measured: 14 weeks
Patient Global Impression of Change
Measured: 14 weeks
Multidimensional Assessment of Fatigue
Measured: 14 weeks
Hospital Anxiety and Depression Scale
Measured: 14 weeks
Short Form 36
Measured: 14 weeks
Sheehan Disability Score
Measured: 14 weeks
Pain Visual Analogue Scale
Measured: 14 weeks

Timeline

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

Dec 2007May 2009

First posted11 Feb 2008 (estimated)
Study startDec 2007
Primary completionMay 2009
Study completionMay 2009

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.
More trials run by PfizerThe sponsor's other registered studies.
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: 1,129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00612170
Sponsor's protocol ID: A6061043
Other IDs: A6061043
Status last verified: Dec 2019
First submitted: 29 Jan 2008
Last updated: 12 Dec 2019
Results posted: No
Data monitoring committee: Yes

Publications

Arnold LM, Hirsch I, Sanders P, Ellis A, Hughes B. Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2012 Jul;64(7):2387-97. doi: 10.1002/art.34390.
PubMed 22275142

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

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

All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT00612170
Acronym / sponsor ID: A6061043
Conditions: Fibromyalgia
Keywords: Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,129 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 11 Feb 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
3	Experimental	Drug: [S,S]-Reboxetine
4	Sham comparator	Drug: Placebo
1	Experimental	Drug: [S,S]-Reboxetine
2	Experimental	Drug: [S,S]-Reboxetine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female of any race, at least 18 years of age
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)

Key exclusion criteria (4 listed)

Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features

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
[S,S]-Reboxetine10 mg oral tablet once a day dosing	Drug	3
Placebo0 mg oral tablet once a day dosing	Drug	4
[S,S]-Reboxetine4 mg oral tablet once a day dosing	Drug	1
[S,S]-Reboxetine8 mg oral tablet once a day dosing	Drug	2

Primary outcome

Change from baseline in the endpoint mean pain score
Time frame: 14 weeks
Fibromyalgia Impact Questionnaire
Time frame: 14 weeks

7 secondary outcomes

Change from baseline in the endpoint mean sleep interference score
Time frame: 14 weeks
Patient Global Impression of Change
Time frame: 14 weeks
Multidimensional Assessment of Fatigue
Time frame: 14 weeks
Hospital Anxiety and Depression Scale
Time frame: 14 weeks
Short Form 36
Time frame: 14 weeks
Sheehan Disability Score
Time frame: 14 weeks
Pain Visual Analogue Scale
Time frame: 14 weeks

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 12 Dec 2019.
Derived from this study: PubMed 22275142Arnold LM, Hirsch I, Sanders P, Ellis A, Hughes B. Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2012 Jul;64(7):2387-97. doi: 10.1002/art.34390.
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

145 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [S,S]-Reboxetine in people with Fibromyalgia, run by Pfizer at 145 sites in 2 countries.

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 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Canada. 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?

Change from baseline in the endpoint mean pain score (time frame: 14 weeks). The study lists 2 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 NCT00612170, 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 12 Dec 2019.