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

NCT00612170 | Completed Phase 3 DMC

• 1 other identifier: A6061043
• Study Type: interventional
• Target: 1,129
• Locations: 2 countries
• Sites: 145

Brief 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.

Conditions

Fibromyalgia

Keywords

Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the endpoint mean pain score

  14 weeks

• Fibromyalgia Impact Questionnaire

  14 weeks

Secondary Outcomes (7)

• Change from baseline in the endpoint mean sleep interference score

  14 weeks

• Patient Global Impression of Change

  14 weeks

• Multidimensional Assessment of Fatigue

  14 weeks

• Hospital Anxiety and Depression Scale

  14 weeks

• Short Form 36

  14 weeks

Study Arms (4)

3

EXPERIMENTAL

Drug: [S,S]-Reboxetine

4

SHAM COMPARATOR

Drug: Placebo

1

EXPERIMENTAL

Drug: [S,S]-Reboxetine

2

EXPERIMENTAL

Drug: [S,S]-Reboxetine

Interventions

[S,S]-Reboxetine DRUG

10 mg oral tablet once a day dosing

3

Placebo DRUG

0 mg oral tablet once a day dosing

4

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)

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 (145)

Pfizer Investigational Site

Birmingham, Alabama, 35242, United States

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Huntsville, Alabama, 35802, United States

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Tallassee, Alabama, 36078, United States

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Chandler, Arizona, 85225, United States

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Phoenix, Arizona, 85023, United States

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Tucson, Arizona, 85741, United States

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Carmichael, California, 95608, 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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Sacramento, California, 95823, 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, 34601, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32223, United States

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Jacksonville, Florida, 32257, United States

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Ocala, Florida, 34471, United States

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Ocala, Florida, 34474, United States

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Sarasota, Florida, 34233, 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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Venice, Florida, 34292, 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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Atlanta, Georgia, 30342, United States

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Aurora, Illinois, 60504, 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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Dubuque, Iowa, 52001, 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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Lexington, Kentucky, 40509, 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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Rochester, Minnesota, 55905, 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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Henderson, Nevada, 89014, United States

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Henderson, Nevada, 89015, 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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New York, New York, 10021, United States

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New York, New York, 10022-1009, 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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Cincinnati, Ohio, 45249, United States

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Cleveland, Ohio, 44122, 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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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, 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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Portland, Oregon, 97239, 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, 15243, United States

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West Reading, Pennsylvania, 19611-1124, United States

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Willow Grove, Pennsylvania, 19090, United States

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Cumberland, Rhode Island, 02864, United States

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Lincoln, Rhode Island, 02865, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29412, United States

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Bristol, Tennessee, 37620, United States

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Jackson, Tennessee, 38305, United States

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Johnson City, Tennessee, 37601, United States

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Kingsport, Tennessee, 37660, United States

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Milan, Tennessee, 38358, 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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Beaumont, Texas, 77706, 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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Houston, Texas, 77063, 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, 78213, 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, 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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Seattle, Washington, 98104, United States

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Seattle, Washington, 98122, United States

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Spokane, Washington, 99216, United States

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Milwaukee, Wisconsin, 53209, 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, M3H 5S4, 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 Publications (1)

• 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.

  PMID: 22275142 DERIVED

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

US (136); CA (9)