Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

NCT ID: NCT00607256

Last Updated: 2019-12-13

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-20

Study Completion Date

2009-05-18

Brief Summary

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To evaluate the lon-term safety and tolerability of \[S,S\]-reboxetine in patients with fibromyalgia

Detailed Description

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Conditions

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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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Open Label

Group Type EXPERIMENTAL

[S,S]-reboxetine

Intervention Type DRUG

S\_S reboxetine dosed daily.

Interventions

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[S,S]-reboxetine

S\_S reboxetine dosed daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria

* Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
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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Pfizer Investigational Site

Orangevale, California, United States

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Santa Ana, California, United States

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Denver, Colorado, 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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West Palm Beach, Florida, United States

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Moline, Illinois, United States

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Prairie Village, Kansas, United States

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Lexington, Kentucky, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Kenilworth, New Jersey, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Cary, North Carolina, United States

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Minot, North Dakota, United States

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Cincinnati, Ohio, United States

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Marion, Ohio, United States

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Medford, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Cumberland, Rhode Island, United States

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Lincoln, Rhode Island, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Brussels, , Belgium

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Pellenberg, , Belgium

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Kelowna, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Pointe-Claire, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Hlučín, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Zlín, , Czechia

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Lille, Cedex, France

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Nice, , France

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Paris, , France

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Berlin, , Germany

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Berlin, , Germany

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Eichstätt, , Germany

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Göppingen, , Germany

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Hamburg, , Germany

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Mannheim, , Germany

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München, , Germany

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Wiesbaden, , Germany

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Breda, , Netherlands

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Emmen, , Netherlands

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Leeuwarden, , Netherlands

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Boksburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Panorama, Western Cape, South Africa

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Parow, Western Cape, South Africa

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Suwon, Kyeongki-do, South Korea

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Gwangju, , South Korea

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Gothenburg, , Sweden

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Mölndal, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Cambridge, , United Kingdom

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Colchester, , United Kingdom

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Derby, , United Kingdom

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Dudley, West Midlands, , United Kingdom

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Greenock, , United Kingdom

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Paisley, , United Kingdom

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Countries

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United States Belgium Canada Czechia France Germany Netherlands South Africa South Korea Sweden United Kingdom

Related Links

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Other Identifiers

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A6061046

Identifier Type: -

Identifier Source: org_study_id