Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia

NCT00754221 | Terminated Phase 3 DMC

• 1 other identifier: A6061053
• Study Type: interventional
• Target: 390
• Locations: 2 countries
• Sites: 109

Brief Summary

This is a study to investigate the long-term safety and effectiveness \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.

Conditions

Fibromyalgia

Keywords

Phase 3, safety study, [S,S]-Reboxetine, Fibromyalgia

Outcome Measures

Primary Outcomes (4)

• Vital Signs

  66 weeks

• 12-Lead ECG

  66 weeks

• Hematology & Biochemistry Laboratory Parameters

  66 weeks

• Adverse Events

  66 weeks

Secondary Outcomes (5)

• Short-Form 36 Health Survey

  66 weeks

• Sheehan Disability Scale

  66 weeks

• Pain Visual Analogue Scale

  66 weeks

• Multidimensional Assessment of Fatigue

  66 weeks

• Fibromyalgia Impact Questionaire

  66 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: [S,S]-Reboxetine

Interventions

[S,S]-Reboxetine DRUG

Once a day, oral treatment, of 4, 6, 8 or 10 mg

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (109)

Pfizer Investigational Site

Birmingham, Alabama, 35242, United States

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Phoenix, Arizona, 85023, United States

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Tucson, Arizona, 85741, United States

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Elk Grove, California, 95758, United States

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Fullerton, California, 92835, United States

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Lafayette, California, 94549, United States

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Northridge, California, 91325, United States

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Oceanside, California, 92056, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95816, United States

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San Jose, California, 95124, United States

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Santa Ana, California, 92705, United States

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New London, Connecticut, 06320, United States

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Brooksville, Florida, 34613, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32223, United States

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Ocala, Florida, 34471, United States

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Ocala, Florida, 34474, United States

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St. Petersburg, Florida, 33709, United States

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Sunrise, Florida, 33351, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33614, United States

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West Palm Beach, Florida, 33407, United States

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Winter Haven, Florida, 33880, United States

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Atlanta, Georgia, 30328, United States

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Gurnee, Illinois, 60031, United States

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Moline, Illinois, 61265, United States

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Oak Brook, Illinois, 60523, United States

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Indianapolis, Indiana, 46250, United States

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Indianapolis, Indiana, 46260, United States

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Overland Park, Kansas, 66212, United States

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Overland Park, Kansas, 66215, United States

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Pratt, Kansas, 67124, United States

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Louisville, Kentucky, 40213, United States

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Madisonville, Kentucky, 42431, United States

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Mount Sterling, Kentucky, 40353, United States

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Baton Rouge, Louisiana, 70809, United States

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Wheaton, Maryland, 20902, United States

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Boston, Massachusetts, 02135, United States

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Brockton, Massachusetts, 02301, United States

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Fall River, Massachusetts, 02720, United States

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North Dartmouth, Massachusetts, 02747, United States

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Watertown, Massachusetts, 02472, United States

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Wellesley Hills, Massachusetts, 02481-2106, United States

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Worcester, Massachusetts, 01610, United States

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Ann Arbor, Michigan, 48103, United States

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Chaska, Minnesota, 55318, United States

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Edina, Minnesota, 55435, United States

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Olive Branch, Mississippi, 38654, United States

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Columbia, Missouri, 65203, United States

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Columbia, Missouri, 65212, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89119, United States

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Albuquerque, New Mexico, 87109, United States

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Albany, New York, 12205, United States

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Brooklyn, New York, 11235, United States

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Rochester, New York, 14610, United States

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Rochester, New York, 14618, United States

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The Bronx, New York, 10454, United States

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Charlotte, North Carolina, 28209-3734, United States

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Salisbury, North Carolina, 28144, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45227, United States

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Columbus, Ohio, 43213, United States

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Dayton, Ohio, 45408, United States

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Toledo, Ohio, 43623, United States

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Bend, Oregon, 97701, United States

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Eugene, Oregon, 97401, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97219, United States

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Altoona, Pennsylvania, 16602, United States

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Bethlehem, Pennsylvania, 18015, United States

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Bridgeville, Pennsylvania, 15017, United States

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Duncansville, Pennsylvania, 16635, United States

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Pittsburgh, Pennsylvania, 15216, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Pittsburgh, Pennsylvania, 15243, United States

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West Reading, Pennsylvania, 19611-1124, United States

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Cumberland, Rhode Island, 02864, United States

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Bristol, Tennessee, 37620, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78758, United States

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Austin, Texas, 78759, United States

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Beaumont, Texas, 77701, United States

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Bryan, Texas, 77802, United States

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Dallas, Texas, 75231, United States

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DeSoto, Texas, 75115, United States

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Lake Jackson, Texas, 77566, United States

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Nassau Bay, Texas, 77058, United States

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San Antonio, Texas, 78229, United States

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Ogden, Utah, 84405, United States

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Salt Lake City, Utah, 84107, United States

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Arlington, Virginia, 22205-3617, United States

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Charlottesville, Virginia, 22911, United States

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Virginia Beach, Virginia, 23455, United States

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Kirkland, Washington, 98033, United States

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Spokane, Washington, 99216, United States

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Milwaukee, Wisconsin, 53209-0966, United States

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Oregon, Wisconsin, 53575, United States

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Kelowna, British Columbia, V1Y 2H4, Canada

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Bathurst, New Brunswick, E2A 4X7, Canada

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Moncton, New Brunswick, E1G 1A7, Canada

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Hawkesbury, Ontario, K6A 1A1, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Québec, Quebec, G1V 3M7, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Fibromyalgia

Interventions

O-methyl reboxetine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 17, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

CA (8); US (101)