- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754221
Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia
December 15, 2019 updated by: Pfizer
A Multi-center, Long-term, Open-label Extension Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
This is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
390
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G1V 3M7
- Pfizer Investigational Site
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 2H4
- Pfizer Investigational Site
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New Brunswick
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Bathurst, New Brunswick, Canada, E2A 4X7
- Pfizer Investigational Site
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Moncton, New Brunswick, Canada, E1G 1A7
- Pfizer Investigational Site
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Ontario
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Hawkesbury, Ontario, Canada, K6A 1A1
- Pfizer Investigational Site
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Toronto, Ontario, Canada, M9W 4L6
- Pfizer Investigational Site
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Quebec
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Pointe Claire, Quebec, Canada, H9R 3J1
- Pfizer Investigational Site
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Sherbrooke, Quebec, Canada, J1H 1Z1
- Pfizer Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35242
- Pfizer Investigational Site
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Arizona
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Phoenix, Arizona, United States, 85023
- Pfizer Investigational Site
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Tucson, Arizona, United States, 85741
- Pfizer Investigational Site
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California
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Elk Grove, California, United States, 95758
- Pfizer Investigational Site
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Fullerton, California, United States, 92835
- Pfizer Investigational Site
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Lafayette, California, United States, 94549
- Pfizer Investigational Site
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Northridge, California, United States, 91325
- Pfizer Investigational Site
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Oceanside, California, United States, 92056
- Pfizer Investigational Site
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Roseville, California, United States, 95661
- Pfizer Investigational Site
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Sacramento, California, United States, 95816
- Pfizer Investigational Site
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San Jose, California, United States, 95124
- Pfizer Investigational Site
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Santa Ana, California, United States, 92705
- Pfizer Investigational Site
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Connecticut
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New London, Connecticut, United States, 06320
- Pfizer Investigational Site
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Florida
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Brooksville, Florida, United States, 34613
- Pfizer Investigational Site
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Jacksonville, Florida, United States, 32216
- Pfizer Investigational Site
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Jacksonville, Florida, United States, 32223
- Pfizer Investigational Site
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Ocala, Florida, United States, 34471
- Pfizer Investigational Site
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Ocala, Florida, United States, 34474
- Pfizer Investigational Site
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Saint Petersburg, Florida, United States, 33709
- Pfizer Investigational Site
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Sunrise, Florida, United States, 33351
- Pfizer Investigational Site
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Tampa, Florida, United States, 33614
- Pfizer Investigational Site
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Tampa, Florida, United States, 33606
- Pfizer Investigational Site
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West Palm Beach, Florida, United States, 33407
- Pfizer Investigational Site
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Winter Haven, Florida, United States, 33880
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30328
- Pfizer Investigational Site
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Illinois
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Gurnee, Illinois, United States, 60031
- Pfizer Investigational Site
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Moline, Illinois, United States, 61265
- Pfizer Investigational Site
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Oak Brook, Illinois, United States, 60523
- Pfizer Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46250
- Pfizer Investigational Site
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Indianapolis, Indiana, United States, 46260
- Pfizer Investigational Site
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Kansas
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Overland Park, Kansas, United States, 66212
- Pfizer Investigational Site
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Overland Park, Kansas, United States, 66215
- Pfizer Investigational Site
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Pratt, Kansas, United States, 67124
- Pfizer Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40213
- Pfizer Investigational Site
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Madisonville, Kentucky, United States, 42431
- Pfizer Investigational Site
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Mount Sterling, Kentucky, United States, 40353
- Pfizer Investigational Site
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Pfizer Investigational Site
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Maryland
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Wheaton, Maryland, United States, 20902
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02135
- Pfizer Investigational Site
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Brockton, Massachusetts, United States, 02301
- Pfizer Investigational Site
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Fall River, Massachusetts, United States, 02720
- Pfizer Investigational Site
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North Dartmouth, Massachusetts, United States, 02747
- Pfizer Investigational Site
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Watertown, Massachusetts, United States, 02472
- Pfizer Investigational Site
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Wellesley Hills, Massachusetts, United States, 02481-2106
- Pfizer Investigational Site
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Worcester, Massachusetts, United States, 01610
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, United States, 48103
- Pfizer Investigational Site
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Minnesota
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Chaska, Minnesota, United States, 55318
- Pfizer Investigational Site
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Edina, Minnesota, United States, 55435
- Pfizer Investigational Site
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Mississippi
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Olive Branch, Mississippi, United States, 38654
- Pfizer Investigational Site
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Missouri
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Columbia, Missouri, United States, 65203
- Pfizer Investigational Site
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Columbia, Missouri, United States, 65212
- Pfizer Investigational Site
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Jefferson City, Missouri, United States, 65109
- Pfizer Investigational Site
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Saint Louis, Missouri, United States, 63141
- Pfizer Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68134
- Pfizer Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89119
- Pfizer Investigational Site
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Pfizer Investigational Site
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New York
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Albany, New York, United States, 12205
- Pfizer Investigational Site
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Bronx, New York, United States, 10454
- Pfizer Investigational Site
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Brooklyn, New York, United States, 11235
- Pfizer Investigational Site
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Rochester, New York, United States, 14618
- Pfizer Investigational Site
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Rochester, New York, United States, 14610
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28209-3734
- Pfizer Investigational Site
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Salisbury, North Carolina, United States, 28144
- Pfizer Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45219
- Pfizer Investigational Site
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Cincinnati, Ohio, United States, 45227
- Pfizer Investigational Site
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Columbus, Ohio, United States, 43213
- Pfizer Investigational Site
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Dayton, Ohio, United States, 45408
- Pfizer Investigational Site
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Toledo, Ohio, United States, 43623
- Pfizer Investigational Site
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Oregon
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Bend, Oregon, United States, 97701
- Pfizer Investigational Site
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Eugene, Oregon, United States, 97401
- Pfizer Investigational Site
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Medford, Oregon, United States, 97504
- Pfizer Investigational Site
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Portland, Oregon, United States, 97219
- Pfizer Investigational Site
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- Pfizer Investigational Site
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Bethlehem, Pennsylvania, United States, 18015
- Pfizer Investigational Site
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Bridgeville, Pennsylvania, United States, 15017
- Pfizer Investigational Site
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Duncansville, Pennsylvania, United States, 16635
- Pfizer Investigational Site
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Pittsburgh, Pennsylvania, United States, 15243
- Pfizer Investigational Site
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Pittsburgh, Pennsylvania, United States, 15241
- Pfizer Investigational Site
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Pittsburgh, Pennsylvania, United States, 15216
- Pfizer Investigational Site
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West Reading, Pennsylvania, United States, 19611-1124
- Pfizer Investigational Site
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Rhode Island
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Cumberland, Rhode Island, United States, 02864
- Pfizer Investigational Site
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Tennessee
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Bristol, Tennessee, United States, 37620
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37203
- Pfizer Investigational Site
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Texas
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Austin, Texas, United States, 78759
- Pfizer Investigational Site
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Austin, Texas, United States, 78758
- Pfizer Investigational Site
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Beaumont, Texas, United States, 77701
- Pfizer Investigational Site
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Bryan, Texas, United States, 77802
- Pfizer Investigational Site
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Dallas, Texas, United States, 75231
- Pfizer Investigational Site
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DeSoto, Texas, United States, 75115
- Pfizer Investigational Site
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Lake Jackson, Texas, United States, 77566
- Pfizer Investigational Site
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Nassau Bay, Texas, United States, 77058
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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Utah
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Ogden, Utah, United States, 84405
- Pfizer Investigational Site
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Salt Lake City, Utah, United States, 84107
- Pfizer Investigational Site
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Virginia
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Arlington, Virginia, United States, 22205-3617
- Pfizer Investigational Site
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Charlottesville, Virginia, United States, 22911
- Pfizer Investigational Site
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Virginia Beach, Virginia, United States, 23455
- Pfizer Investigational Site
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Washington
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Kirkland, Washington, United States, 98033
- Pfizer Investigational Site
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Spokane, Washington, United States, 99216
- Pfizer Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53209-0966
- Pfizer Investigational Site
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Oregon, Wisconsin, United States, 53575
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
- Completed preceding double-blind randomized, controlled trial
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Once a day, oral treatment, of 4, 6, 8 or 10 mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Vital Signs
Time Frame: 66 weeks
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66 weeks
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12-Lead ECG
Time Frame: 66 weeks
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66 weeks
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Hematology & Biochemistry Laboratory Parameters
Time Frame: 66 weeks
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66 weeks
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Adverse Events
Time Frame: 66 weeks
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66 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Short-Form 36 Health Survey
Time Frame: 66 weeks
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66 weeks
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Sheehan Disability Scale
Time Frame: 66 weeks
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66 weeks
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Pain Visual Analogue Scale
Time Frame: 66 weeks
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66 weeks
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Multidimensional Assessment of Fatigue
Time Frame: 66 weeks
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66 weeks
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Fibromyalgia Impact Questionaire
Time Frame: 66 weeks
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66 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
September 16, 2008
First Submitted That Met QC Criteria
September 16, 2008
First Posted (Estimate)
September 17, 2008
Study Record Updates
Last Update Posted (Actual)
December 17, 2019
Last Update Submitted That Met QC Criteria
December 15, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Adrenergic Uptake Inhibitors
- Reboxetine
Other Study ID Numbers
- A6061053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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