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

NCT ID: NCT00754221

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

Brief Summary

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

Detailed Description

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Conditions

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Fibromyalgia

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

[S,S]-Reboxetine

Intervention Type DRUG

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

Interventions

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[S,S]-Reboxetine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Elk Grove, California, United States

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Fullerton, California, United States

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Lafayette, California, United States

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Northridge, California, United States

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Oceanside, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Jose, California, United States

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Santa Ana, California, United States

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New London, Connecticut, United States

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Brooksville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Ocala, Florida, United States

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Ocala, Florida, United States

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St. Petersburg, Florida, United States

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Sunrise, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Winter Haven, Florida, United States

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Atlanta, Georgia, United States

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Gurnee, Illinois, United States

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Moline, Illinois, United States

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Oak Brook, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Overland Park, Kansas, United States

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Pratt, Kansas, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Mount Sterling, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Wheaton, Maryland, United States

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Boston, Massachusetts, United States

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Brockton, Massachusetts, United States

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Fall River, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Watertown, Massachusetts, United States

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Wellesley Hills, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Chaska, Minnesota, United States

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Edina, Minnesota, United States

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Olive Branch, Mississippi, United States

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Columbia, Missouri, United States

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Columbia, Missouri, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Salisbury, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Bend, Oregon, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Bridgeville, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Cumberland, Rhode Island, United States

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Bristol, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Bryan, Texas, United States

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Dallas, Texas, United States

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DeSoto, Texas, United States

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Lake Jackson, Texas, United States

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Nassau Bay, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Arlington, Virginia, United States

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Charlottesville, Virginia, United States

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Virginia Beach, Virginia, United States

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Kirkland, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Oregon, Wisconsin, United States

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Kelowna, British Columbia, Canada

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Bathurst, New Brunswick, Canada

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Moncton, New Brunswick, Canada

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Hawkesbury, Ontario, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Countries

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United States Canada

Related Links

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Other Identifiers

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A6061053

Identifier Type: -

Identifier Source: org_study_id